Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 3:50 AM
Study NCT ID:
NCT04143503
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2019-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2019-10-25', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients receiving enteral nutrition (EN), parenteral nutrition (PN), and oral nutrition (ON)/oral nutrition supplements (ONS)', 'timeFrame': 'from admission to ICU until discharge from ICU or death (maximum of 15 days)'}, {'measure': 'Cumulative caloric balance', 'timeFrame': 'from admission to ICU until discharge from ICU or death (maximum of 15 days)'}, {'measure': 'Cumulative protein balance', 'timeFrame': 'from admission to ICU until discharge from ICU or death (maximum of 15 days)'}, {'measure': 'Cumulative calories (kcal/kg and total kcal) administered via EN, PN, ON/ONS, and concomitant medications (e.g. propofol, glucose, citrate, clevidipine), and via all sources combined', 'timeFrame': 'from admission to ICU until discharge from ICU or death (maximum of 15 days)'}, {'measure': 'Cumulative protein (g/kg and total g) administered via EN, PN, ON/ONS, and via all sources combined', 'timeFrame': 'from admission to ICU until discharge from ICU or death (maximum of 15 days)'}, {'measure': 'Proportion of patients with interrupted/stopped or not started clinical nutrition', 'timeFrame': 'from admission to ICU until discharge from ICU or death (maximum of 15 days)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ICU', 'parenteral nutrition', 'enteral nutrition', 'energy intake', 'protein intake'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '35585554', 'type': 'DERIVED', 'citation': 'Matejovic M, Huet O, Dams K, Elke G, Vaquerizo Alonso C, Csomos A, Krzych LJ, Tetamo R, Puthucheary Z, Rooyackers O, Tjader I, Kuechenhoff H, Hartl WH, Hiesmayr M. Medical nutrition therapy and clinical outcomes in critically ill adults: a European multinational, prospective observational cohort study (EuroPN). Crit Care. 2022 May 18;26(1):143. doi: 10.1186/s13054-022-03997-z.'}, {'pmid': '34024501', 'type': 'DERIVED', 'citation': 'Hiesmayr M, Csomos A, Dams K, Elke G, Hartl W, Huet O, Krzych LJ, Kuechenhoff H, Matejovic M, Puthucheary ZA, Rooyackers O, Tetamo R, Tjader I, Vaquerizo C. Protocol for a prospective cohort study on the use of clinical nutrition and assessment of long-term clinical and functional outcomes in critically ill adult patients. Clin Nutr ESPEN. 2021 Jun;43:104-110. doi: 10.1016/j.clnesp.2021.01.048. Epub 2021 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to characterise the use of clinical nutrition support, especially of parenteral nutrition that is administered directly into a vein, in adult patients with critical illness. The study wants to assess nutritional balance (that means the ratio of calories and protein prescribed to calories and protein actually received). Furthermore, it wants to evaluate whether the nutrition received has influence on the patients\' clinical outcome, with focus on measures of physical function, such as capability of conducting daily living activities. As the study is "observational", no specific medications or treatments will be provided as part of the study to the patients.\n\nStudy patients will be observed during their stay on an intensive care unit, for a maximum duration of 15 days. Furthermore, questions on the well-being of the patients will be asked via telephone interviews 30 and 90 days after their admission to the intensive care unit.\n\nData of approximately 1250 patients will be collected and evaluated in this study, from approximately 100 hospitals in 11 European countries (Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Spain, Sweden and United Kingdom).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include adult male and female patients with critical illness (i.e. patients requiring pharmacological and/or technical support to treat a vital threat) who are hospitalised in a medical, surgical, or trauma ICU for at least 5 consecutive calendar days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years and ≤95 years, male or female\n2. Hospitalised in a medical, surgical, or trauma ICU for at least five consecutive calendar days and either admitted to the ICU during the predefined screening month or admitted to the ICU maximally 4 days before start of the screening month\n3. BMI ≥18.5 kg/m2 and ≤45 kg/m2\n4. Written informed consent or requirements of local/national ethical committee\n\nExclusion Criteria:\n\n1. Burn injury\n2. Pre-existing neuromuscular or psychiatric disorders that preclude proper assessment of functional status\n3. Severe hypoxic brain injury or severe neurological diagnosis (e.g. meningitis, encephalitis, brain trauma, spinal cord injury) at the time of ICU admission that precludes proper assessment of functional status\n4. Receiving home parenteral nutrition at the time of ICU admission (e.g. due to short bowel syndrome)\n5. Receiving home enteral nutrition (tube feeding) at the time of ICU admission\n6. Chronic invasive or chronic non-invasive ventilatory support before ICU admission\n7. Patients with a legal representative in place before ICU admission\n8. Admission to the ICU for palliative care\n9. Previous participation in this study (if the screening month is repeated and a patient is re-admitted to the ICU during the repeated screening month, only ICU data collected for that patient during the original screening month will be included)\n10. Concurrent enrolment in a nutrition-related interventional study at the time of screening'}, 'identificationModule': {'nctId': 'NCT04143503', 'briefTitle': 'Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Observational Cohort Study to Characterise the Current Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients Hospitalised in Intensive Care Units in Europe', 'orgStudyIdInfo': {'id': 'NScr-003-CNI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adult critically ill patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '6700', 'city': 'Arlon', 'country': 'Belgium', 'facility': 'Vivalia - Clinique Saint Joseph', 'geoPoint': {'lat': 49.68333, 'lon': 5.81667}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hospital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Clinique Universitaire Saint-Luc - Université Catholique de Louvain (UCL)', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Grand Hôpital de Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '1340', 'city': 'Ottignies', 'country': 'Belgium', 'facility': 'Saint-Pierre Clinic', 'geoPoint': {'lat': 50.66535, 'lon': 4.56679}}, {'zip': '7500', 'city': 'Tournai', 'country': 'Belgium', 'facility': 'Hospital Center of Wallonie Picarde', 'geoPoint': {'lat': 50.60715, 'lon': 3.38932}}, {'zip': '62500', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '62500', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Clinic of Internal Medicine and Gastroenterology, University Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': "St Anne's University Hospital Brno", 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': '3rd Department of Internal Medicine - Metabolic Care and Gerontology, University Hospital Hradec Králové', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Hradec Králové', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'III Internal Gerontometabolic Clinic, University Hospital Hradec Králové', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '77900', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'University Hospital Olomouc Palacky University in Olomouc Faculty of Medicine and Dentistry', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '53003', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Hospital Pardubice Region, Inc.', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '30460', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Charles University Hospital Plzen', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '30460', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'University Hospital Pilsen University Hospital in Pilsen (Fakultní nemocnice Plzeň: Úvodní strana)', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '12808', 'city': 'Prague', 'country': 'Czechia', 'facility': 'General University Hospital Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '15006', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Motol University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '40011', 'city': 'Ústí nad Labem', 'country': 'Czechia', 'facility': 'Masaryk Hospital', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': "Centre Hospitalier Universitaire d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Hôpital de la Cavale Blanche à Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Hospital Center University of Caen Normandie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'country': 'France', 'facility': 'Hôpital Trousseau - Surgical Intensive Care Unit', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Grenoble - Hôpital Michallon', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Hópital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Saint-Étienne - Hopital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '59300', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Centre Hospitalier de Valenciennes', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin - Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitatsmedizin - Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Augusta Kliniken Bochum Hattingen', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '30459', 'city': 'Hanover', 'country': 'Germany', 'facility': 'KRH Klinikum Siloah - Klinik für Gastroenterologie, Interventionelle Endoskopie und Diabetologie', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'UKSH Universitätsklinikum Schleswig-Holstein - Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '04129', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Klinikum St. Georg', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert-Bosch-Krankenhaus', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '35578', 'city': 'Wetzlar', 'country': 'Germany', 'facility': 'Klinikum Wetzlar-Braunfels - Klinik für Geriatrie', 'geoPoint': {'lat': 50.56109, 'lon': 8.50495}}, {'zip': '1096', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Dél-Pesti Centrumkórház - National Institute of Hematology and Infectiology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1134', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'MH EK Honvédkorház', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'University of Debrecen - Department of Anaesthesiology and Intensive Therapy', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Jósa András Oktatókórház', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '8000', 'city': 'Székesfehérvár', 'country': 'Hungary', 'facility': 'Fejér Megyei Szent György Egyetemi Oktató Kórház', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': '8200', 'city': 'Veszprém', 'country': 'Hungary', 'facility': 'Csolnoky Ferenc Kórház', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'zip': '71121', 'city': 'Foggia', 'country': 'Italy', 'facility': 'Ospedali Riuniti di Foggia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '20142', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Paolo', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '84014', 'city': 'Nocera Inferiore', 'country': 'Italy', 'facility': 'Ospedale Umberto I', 'geoPoint': {'lat': 40.7454, 'lon': 14.64542}}, {'zip': '48121', 'city': 'Ravenna', 'country': 'Italy', 'facility': 'Hospital Santa Maria delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '47900', 'city': 'Rimini', 'country': 'Italy', 'facility': 'Ospedale Infermi Rimini', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'zip': '15-276', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny w Białymstoku', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '85-001', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': '10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '40-055', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Medical University of Silesia', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '31-826', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. Z o.o.', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '45-401', 'city': 'Opole', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny w Opolu', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'zip': '60-479', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Szpital Wojewódzki w Poznaniu', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '09006', 'city': 'Burgos', 'country': 'Spain', 'facility': 'Hospital Universitario de Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'Hospital Universitario Dr Josep Trueta de Girona - Intensive Care Unit', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '25198', 'city': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Universitari Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28031', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28942', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Fuenlabrada - Intensive Care Unit', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '07120', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Hospital Universitari Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinic de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '47012', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Universitario Rio Hortega', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '36312', 'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Alvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital, PMI Huddinge, B31', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'L14 3PE', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool Heart and Chest Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'The Royal Liverpool University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal London Hospital, Barts Health NHS Trust & Queen Mary University of London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Michael Hiesmayr, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'IQVIA Commercial GmbH & Co. OHG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}