Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-20 @ 12:43 PM
Study NCT ID:
NCT02832193
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Evaluation of POCD Data of Studies From KAI, Charité - Universitätsmedizin Berlin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Demographics', 'timeFrame': 'Up to 5 years', 'description': 'Demographics are measured by demographic data.'}, {'measure': 'Neurological diseases', 'timeFrame': 'Up to 5 years', 'description': 'Neurological diseases are taken from the hospital record'}, {'measure': 'Waist circumference', 'timeFrame': 'Up to 5 years', 'description': 'Waist circumference is measured in cm.'}, {'measure': 'Hip circumfernece', 'timeFrame': 'Up to 5 years', 'description': 'Hip circumference is measured in cm.'}, {'measure': 'Obesitas', 'timeFrame': 'Up to 5 years', 'description': 'Obesitas is measured by body mass index.'}, {'measure': 'Metamemory Questionnaire (MMQ) contentment scale', 'timeFrame': 'At Baseline', 'description': 'Metamemory Questionnaire (MMQ) contentment scale is a participant-reported measure of memory satisfaction, ability, and strategy use..'}, {'measure': 'Presurgical Cognitive Impairment (PreCI)', 'timeFrame': 'At Baseline', 'description': 'Presurgical cognitive impairment is determined as cognitive performance of a test battery.'}], 'primaryOutcomes': [{'measure': 'Neurocognitive Disorder (NCD)', 'timeFrame': 'Up to 1 year', 'description': "Mild / major neurocognitive disorder 3 (mild / major NCD 'Postoperative cognitive dysfunction (POCD)') and 12 months (mild / major NCD) postoperatively."}, {'measure': 'Postoperative cognitive dysfunction (POCD)', 'timeFrame': 'Up to 1 year', 'description': 'Postoperative cognitive dysfunction (POCD) is defined as relevant change in postoperative cognitive performance compared to baseline (preoperative) cognitive performance.'}], 'secondaryOutcomes': [{'measure': 'Suspected neurocognitive disorder due to MiniCog', 'timeFrame': 'Up to 5 years', 'description': 'The MiniCog is used for cognitive screening. A cut-off value of \\<3 points is interpreted possible mild / major NCD. The Mini-Cog consists of a sub-test for word memory skills and a clock drawing test.'}, {'measure': 'Suspected dementia from MOCA', 'timeFrame': 'Up to 5 years', 'description': 'The Montreal Cognitive Assessment (MOCA) with cut-offs according to normative age-adjusted values is used as dementia screening. The MOCA consists of 13 items, which are rated on a scale from 0 to 30 points.'}, {'measure': 'Neurocognitive Disorder (NCD)', 'timeFrame': 'Up to 5 years', 'description': 'Mild / major neurocognitive disorder (mild / major NCD) 60months postoperatively.'}, {'measure': "Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD')", 'timeFrame': 'Up to 5 years', 'description': 'The non-computerized neuropsychological trail making test is used as an indicator screening test for relevant cognitive changes after the operation. The cut-off is an increase in TMT-B test performance of\\> 55 seconds three and / or 12 months after the operation compared to the baseline value.'}, {'measure': 'Findings from outpatient neurocognitive evaluation (memory clinic)', 'timeFrame': 'Up to 1 year', 'description': 'Results from patient neurocognitive assessment in a memory clinic are evaluated.'}, {'measure': 'Neuroimaging', 'timeFrame': 'Up to 5 years', 'description': 'Technique to image the nervous system.'}, {'measure': 'Normative database', 'timeFrame': 'Up to 5 years', 'description': 'Establishment of a norm database for deriving normative data in a cooperation between the Clinial Research Unit Berlin/Institute of Health (BIH), the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK) at Charité Universitätsmedizin Berlin and Cambridge Cognition.'}, {'measure': 'Perioperative cognitive disorders', 'timeFrame': 'Up to 5 years', 'description': 'Perioperative cognitive disorders for different surgical cohorts are evaluated to describe domain-specific changes over time in formal cognitive tests. These analyzes are carried out in a joint evaluation with Monument Therapeutics as part of a cooperation agreement'}, {'measure': 'Computerized cognitive data', 'timeFrame': 'Up to 5 years', 'description': 'Computerized cognitive data from CANTAB-research suite, CANTAB eclipse and CANTAB connect'}, {'measure': 'Paper-based, non-computerized, cognitive test data', 'timeFrame': 'Up to 5 years', 'description': 'Paper-based, non-computerized, cognitive test data are data from such as IQ equivalent (e.g. MWT-A), MMSE, MOCA, MMQ, Mini-Cog, etc.'}, {'measure': 'Socio-economic Information 1', 'timeFrame': 'Up to 5 years', 'description': 'Soci-economic information is collected by FIMA'}, {'measure': 'Socio-economic Information 2', 'timeFrame': 'Up to 5 years', 'description': 'Soci-economic information is collected by a questionnaire according to Nikolaus 1. Subscale'}, {'measure': 'Comorbidities', 'timeFrame': 'Up to 5 years', 'description': 'Comorbidities are new diagnoses from hospital records.'}, {'measure': 'Charlson comorbidity index', 'timeFrame': 'Up to 5 years', 'description': 'Comorbidity scores'}, {'measure': 'Lifestyle Risks 1', 'timeFrame': 'Up to 5 years', 'description': 'Consumption of alcohol per week.'}, {'measure': 'Lifestyle Risks 2', 'timeFrame': 'Up to 5 years', 'description': 'Consumption of tobacco and nicotine is measured by Fagerström Test for Cigarette Dependence (FTCD). Questionnaire scored 0-10 points with Total Score equal to the sum of all points'}, {'measure': 'Level of education', 'timeFrame': 'Up to 5 years', 'description': 'Level of education is measured by ISCED'}, {'measure': 'Incidence of postoperative delirium', 'timeFrame': 'Up to 5 years', 'description': 'Incidence of postoperative delirium is measured by DDS, DSM-V, CAM/CAM-ICU, NuDESC and Chart review'}, {'measure': 'Duration of postoperative delirium', 'timeFrame': 'Up to 5 years', 'description': 'The Duration of postoperative Delirium is measured in days'}, {'measure': 'Severity of postoperative delirium 1', 'timeFrame': 'Up to 5 years', 'description': 'Severity of delirium 1 is measured by Delirium Detection Score (DDS). The DDS is composed of eight criteria (orientation, hallucination, agitation, anxiety, seizures, tremor, paroxysmal sweating, and altered sleep- wake rhythm). Each item is cored 0,1,4, or 7 points for a possible total score of 0 to 56). Positive if \\>7.'}, {'measure': 'Severity of postoperative delirium 2', 'timeFrame': 'Up to 5 years', 'description': 'Severity of delirium 2 is measured by Confusion assessment method-short (CAM-S). This is a CAM-based scoring system for delirium severity. The CAM-S uses the same items as the original CAM and rates each symptom 0 for absent, 1 for mild, or 2 for marked; acute onset of fluctuation receives 0 (absent) or 1 (present) (scored 0-10, higher worse).'}, {'measure': 'Severity of postoperative delirium 3', 'timeFrame': 'Up to 5 years', 'description': 'Severity of delirium 3 is measured by DSR-R-98. DRS-R-98 is 16 items clinician rated scale. Total Item: 16 = 3 (for diagnosis) + 13 (for severity).'}, {'measure': 'Severity of postoperative delirium 4', 'timeFrame': 'Up to 5 years', 'description': 'Severity of delirium 4 is measured by ICDSC. Give a score of "1" to each of the 8 items below if the patient clearly meets the criteria defined in the scoring instructions. Give a score of "0" if there is no manifestation orunable to score. If the patient scores \\>4, notify the physician. The diagnosis of delirium is made following clinical assessment. assessment.'}, {'measure': 'Severity of postoperative delirium 5', 'timeFrame': 'Up to 5 years', 'description': "Severity of delirium 5 is measured by Nursing Delirium Screening Scale (Nu-DESC). The Nu-DESC is a scale that evaluates the severity of the 5 delirium characteristics on a scale of 0 (not present) to 2 (severe) and takes only 1-2 min to complete, based on the nurses' observations of the patient's behavior during their shifts."}, {'measure': 'Length of hospital stay', 'timeFrame': 'Up to 5 years', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 7 days'}, {'measure': 'Quality of life - relatives', 'timeFrame': 'Up to 5 years', 'description': 'Quality of life is measured by CarerQoL'}, {'measure': 'Quality of life - self 1', 'timeFrame': 'Up to 5 years', 'description': 'Quality of life is measured by EQ-5D.An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.'}, {'measure': 'Quality of life - self 2', 'timeFrame': 'Up to 5 years', 'description': 'Quality of life is measured by WHO-5. WHO-5 is a short and generic global rating scale measuring subjective well-being, the respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score ranges from 0 (absence of well-being) to 25 (maximal well-being). Scores are then converted to a percentage scale from 0 (absent) to 100 (maximal). Higher scores represent greater psychological well-being.'}, {'measure': 'Functional impairment (IADL) 1', 'timeFrame': 'Up to 5 years', 'description': 'Instrumental Activities of Daily Living (IADLs) \\< 8'}, {'measure': 'Functional impairment (ADL) 2', 'timeFrame': 'Up to 5 years', 'description': 'Activities of Daily Living (ADLs) \\< 100'}, {'measure': 'Depression 1', 'timeFrame': 'Up to 5 years', 'description': 'Depression 1 is measured by PHQ-8'}, {'measure': 'Depression 2', 'timeFrame': 'Up to 5 years', 'description': 'Depression 2 is measured by GDS'}, {'measure': 'Anxiety scales', 'timeFrame': 'Up to 5 years', 'description': 'Anxiety is measured by GAD-7'}, {'measure': 'Pain', 'timeFrame': 'Up to 5 years', 'description': 'Pain is measured by different scales, e.g. Numeric Rating Scale'}, {'measure': 'Depth of sedation', 'timeFrame': 'Up to 5 years', 'description': 'The sedation is emasured intraoperatively processed electroencephalogram (EEG) Full-brain EEG recording with surface electrodes, raw EEG analysis measured during the operation.'}, {'measure': 'Sedation', 'timeFrame': 'Up to 5 years', 'description': 'Sedation is measured by the Richmond Agitation Sedation Scale'}, {'measure': 'Type of operation', 'timeFrame': 'Up to 5 years', 'description': 'Type of operation is measured by OPS-Code.'}, {'measure': 'Type of anesthesia', 'timeFrame': 'Up to 5 years', 'description': 'There are four main categories of anesthesia used during surgery and other procedures: general anesthesia, regional anesthesia, sedation (sometimes called "monitored anesthesia care"), and local anesthesia.'}, {'measure': 'Type of concomitant medication', 'timeFrame': 'Up to 5 years', 'description': 'The medication administered during the hospital stay is documented.'}, {'measure': 'Anticholinergic Load', 'timeFrame': 'Up to 5 years', 'description': 'Measured by anticholinergic drug scale'}, {'measure': 'Frailty', 'timeFrame': 'Up to 5 years', 'description': 'Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.'}, {'measure': 'Number of participants with changes in laboratory values 1', 'timeFrame': 'Up to 5 years', 'description': 'Laboratory results in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) count and inflammatory markers from blood samples.'}, {'measure': 'Number of participants with changes in laboratory values 2', 'timeFrame': 'Up to 5 years', 'description': 'Laboratory results in the hospital from serum samples'}, {'measure': 'Number of participants with changes in laboratory values 3', 'timeFrame': 'Up to 5 years', 'description': 'Laboratory results in the hospital from urine samples'}, {'measure': 'Number of participants with changes in laboratory values 4', 'timeFrame': 'Up to 5 years', 'description': 'Laboratory results in the hospital from stool samples'}, {'measure': 'Perioperative Electroencephalography', 'timeFrame': 'During hospital stay an expected avarage of 7 days', 'description': 'Electroencephalography (EEG)- Mapping with electrodes.'}, {'measure': 'Nutritional status 1', 'timeFrame': 'Up to five years', 'description': 'Nutritional status 1 is measured by calf circumference'}, {'measure': 'Nutritional status 2', 'timeFrame': 'Up to five years', 'description': 'Nutritional status 2 is measured by arm circumference'}, {'measure': 'Nutritional status 3', 'timeFrame': 'Up to five years', 'description': 'Nutritional status 3 is measured by changes in weight'}, {'measure': 'Nutritional status 4', 'timeFrame': 'Up to five years', 'description': 'Nutritional status 4 is measured by changes in body mass index'}, {'measure': 'Nutritional status 5', 'timeFrame': 'Up to five years', 'description': 'Nutritional status 5 is measured by questions regarding microbiome'}, {'measure': 'Nutritional status 6', 'timeFrame': 'Up to five years', 'description': 'Nutritional status 6 is measured by Medi-Score'}, {'measure': 'Nutritional status 7', 'timeFrame': 'Up to five years', 'description': 'Nutritional status 7 is measured by MNA-SF'}, {'measure': 'Nutritional status 8', 'timeFrame': 'Up to five years', 'description': 'Nutritional status 8 is measured by Sarcopenia, which is identified by criterion 1: low muscle strength, criterion 2: low muscle quantity and criterion 3: low physical performance. Probable sarcopenia is identified by Criterion 1. Diagnosis is confirmed by additional documentation of Criterion 2.\n\nIf Criteria 1, 2 and 3 are all met, sarcopenia is considered severe.'}, {'measure': 'Inhospital diet', 'timeFrame': 'Up to five years', 'description': 'Inhospital diet is measured by patient record.'}, {'measure': 'Eating habits', 'timeFrame': 'Up to five years', 'description': 'Eating habits are measured by patient survey.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Cognitive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '11207462', 'type': 'BACKGROUND', 'citation': 'Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. doi: 10.1034/j.1399-6576.2001.045003275.x.'}, {'pmid': '30336844', 'type': 'BACKGROUND', 'citation': 'Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'Data on prevention of perioperative neurocognitive disorders (pNCDs) are limited. The purpose of this monocentric parallel - grouped observational registry is to collect study data from studies with pNCDs as primary or secondary endpoint to estimate prevalence and incidence of pNCDs.', 'detailedDescription': 'Perioperative cognitive trajectories (Perioperative neurocognitive disorders \\[pNCDs\\]) are described with formal cognitive testing (neurocognitive test battery). Definitions are based on current nomenclature recommendations (Evered et al.) according to DSM-V criteria including a multi-component cognitive test battery comparing baseline and postoperative follow-up testing of patients with cognitive test performance of non-surgical control groups.Cognitive concern and functional ability are described with items from questionnaires, e.g. IQCODE, MMQ, GDS, ADL/IADL and others specific to the respective study design.\n\nRepeated cognitive testing with a battery of computerized neuropsychological tests (Cambridge Neuropsychological Test Automated Battery \\[CANTAB®\\]) and non computerized (paper based)tests (e.g. trailmaking test, Grooved pegboard test, Stroop color word interference test, animal naming test, etc.) are performed at preoperative baseline, after 5-7 days and at three months follow up, 1 year, 2 years and 5 years follow-up according to the study design of the registered studies.\n\nDifferent calculation methods will be applied to the cognitive test data, primarily the dichotomousapproach established by Rasmussen et al. in the International Study on postoperative cognitive deficits (ISPOCD). This calculation method defines POCD as a reliable change in pre- and postoperative cognitive performance (difference scores) of each individual in the surgical patients cohort as compared to the changes in a non-surgical control group (reliable change index in either a composite score including cognitive test parameters from all tests in the cognitive test battery or in at least two of the chosen cognitive test parameters). Additional calculation methods like "g-factor", "GCP" and arbitrary definitions e.g. "20.20- rule" will be used for detailed methodologic evaluation.\n\nIn two subprojects we plan to describe domain-specific changes in formal cognitive testing over the registered surgical cohorts.\n\nSubproject 1-Analyses will be performed in joint evaluation with Monument Therapeutics (Spin off Cambridge Cognition). The analyses aim to :\n\n1. Describe cognitive change based on raw cognitive data from the applied cognitive test battery (computerized tests with CANTAB eclipse, CANTAB research suite, CANTAB connect and non-computerized tests)\n2. Identify predisposing factors (e.g. patient characteristics, biomarkers, medications) predictive of cognitive decline following surgery\n3. Identify the cognitive domains most sensitive to neuropsychological change following surgery\n\nSubproject 2-Analyses will be performed in joint evaluation with Cambridge Cognition. The analyses aim to :\n\nFacilitate the use of data collected from non-surgical controls as normative material for future studies in the research area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients undergoing surgery, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany', 'healthyVolunteers': True, 'eligibilityCriteria': 'Study Group\n\nInclusion Criteria:\n\n* Age 18 -100 years\n* Male or female patients undergoing elective surgery expected to last at least 60 min, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany\n* Written informed consent to participate after having been properly instructed\n\nExclusion Criteria:\n\n* Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study\n* Accommodation in an institution due to an official or judicial order\n* Insufficient knowledge of German language\n* Members of the hospital staff\n* Homelessness or other conditions that disable reachability for postoperative assessment by post or telephone\n* Illiteracy\n* Patients who had a history of neurologic deficits (e.g. stroke, history of seizures, etc.)\n* Hearing impairment that severely affects the neuropsychological testing.\n* Visual impairment that severely affects the neuropsychological testing.\n* Participation in other prospective clinical interventional trials\n\nControl Group\n\nInclusion Criteria:\n\n* Age 18 - 100 years\n* Male or female patients (ASA Status I, II+III)\n* No planned surgery during the next 3 months\n* No surgery during the past 6 months before study inclusion\n* Written informed consent to participate after having been properly instructed\n\nExclusion Criteria:\n\n* Insufficient knowledge of German language Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study\n* Neuropsychiatric conditions that severely affect the neuropsychological testing\n* Hearing impairment that severely affects the neuropsychological testing\n* Visual impairment that severely affects the neuropsychological testing'}, 'identificationModule': {'nctId': 'NCT02832193', 'briefTitle': 'Retrospective Evaluation of POCD Data of Studies From KAI, Charité - Universitätsmedizin Berlin', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Retrospective Evaluation of POCD Data of Studies From the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK) Charité - Universitätsmedizin Berlin', 'orgStudyIdInfo': {'id': 'POCD-Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'POCD data of study patients of the following studies:\n\nPhydelio - Eudract.-No.: 2008-007237-47 - 08/0618 ZS EK11 Neuprodex - Eudract-No.: 2013 -000823-15 - 13/0491 ZSEK11 BioCog - EA2/092/14 Cognitive Outcome after two stage liver operation - EA1/296/12 ReCosa - EA1/056/13 Hypnoc - EA1/273/11 Sudoco - EA1/242/08 Peratecs - EA1/241/08 Hipster - Eudract.-No.: 2009-016043-19 100/10 ZS EK15 Pain-Long-EA2/041/17 PCI - EA2/024/18 PODSPA - EA4/138/18, PRÄP-GO -EA1/225/19, ANA-PRÄP-Go (EA1/266/20) Further studies from the Department of Anesthesiology and Operative Intensive Care Medince (CCM/CVK), Charité - Universitätsmedizin Berlin'}, {'label': 'Control group I', 'description': 'POCD data of prospective control subjects/patients (ASA I+II+III) and POCD data of control subjects/patients of the following studies:\n\nNeuprodex - Eudract-No.: 2013 -000823-15 - 13/0491 ZSEK11 Phydeliostudie - Eudract.-No.: 2008-007237-47 - 08/0618 ZS EK11 BioCog - EA2/092/14 Cognitive Outcome after two stage liver operation - EA1/296/12 Hypnoc - EA1/273/11 Sudoco - EA1/242/08 Peratecs - EA1/241/08 Hipster - Eudract.-No.: 2009-016043-19 100/10 ZS EK15 BioCog-Studie - EA2/092/14 REACT-Studie - EA2/091/15 PAINLONG-Studie - EA2/041/17 PCI - EA2/024/18 PODSPA - EA4/138/18, PRÄP-GO -EA1/225/19, ANA-PRÄP-Go (EA1/266/20) Further studies from the Department of Anesthesiology and Operative Intensive Care Medince (CCM/CVK), Charité - Universitätsmedizin Berlin'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12163', 'city': 'Berlin', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Irmgard Landgraf, MD', 'role': 'CONTACT', 'email': 'praxislandgraf@gmail.com', 'phone': '+49 30 450 85726877'}], 'facility': 'Irmgard Landgraf', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'CONTACT', 'email': 'claudia.spies@charite.de', 'phone': '+49 30 450 55 10 01'}, {'name': 'Claudia Spies, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Friedrich Borchers, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'CONTACT', 'email': 'claudia.spies@charite.de', 'phone': '+49 30 450 5510 01'}], 'overallOfficials': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK)', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}