Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT02771002
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2016-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Peripheral Perfusion in the Critically Ill Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'blood samples for detecting lactate'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-21', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'sonographic assesment of solid organ perfusion', 'timeFrame': 'within 24h after ICU admission and 24h after first measurement', 'description': 'solid organ perfusion measured by ultrasound'}], 'primaryOutcomes': [{'measure': 'peripheral perfusion index', 'timeFrame': 'measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)', 'description': 'PPI in healthy controls, septic shock patients and patients rewarming after cardiac surgery'}], 'secondaryOutcomes': [{'measure': 'capillary refill time', 'timeFrame': 'measurement at ICU admission and hourly till extubation or normalization of lactate, during the hospitalization without follow-up (maximal up to 72h)', 'description': 'CRT in healthy controls, septic shock patients and patients rewarming after cardiac surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['critically ill patients', 'septic shock', 'peripheral perfusion index', 'capillary refill time', 'mottling score', 'microcirculation'], 'conditions': ['Peripheral Perfusion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate PPI as a surrogate for clinical signs of peripheral perfusion in patients in septic shock and after cardiac surgery.', 'detailedDescription': 'The aim of this study is to validate PPI as a continuous, objective measurement of peripheral perfusion indicated by clinical sings of tissue perfusion in patients with septic shock. Furthermore, PPI shall be compared to the perfusion of solid organs evaluated by ultrasound of liver, kidney and gut. In a group of healthy volunteers the investigators will determine normal values in ambient temperature and after cooling of an extremity. Another group of patients after cardiac surgery, where usually a poor tissue perfusion without metabolic failure is present will serve as another "control" population in their post-surgery stabilization period. The values from healthy volunteers and cardiac surgery patients will be compared to those of patients in septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female and male septic shock patients with ICU admission Female and male patients after cardiac surgery with ICU admission healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Septic patient:\n\nInclusion criteria:\n\n* ICU admission with septic shock defined as:\n* documented infection (suspected or confirmed) AND\n* systemic mean blood pressure \\<65mmHg requiring any dose of vasopressor despite adequate fluid resuscitation (min. 20ml/kg crystalloids) AND\n* lactate \\>2mmol/l\n* Deferred consent by a relative with following informed consent by patient as documented by signatures (Appendix Informed Consent Form)\n\nExclusion criteria:\n\n* Age \\<18 or \\>80 years\n* present or suspected myocardial ischemia\n* acute pulmonary embolism\n* known liver disease - Child-Pugh -Class B or C\n* known chronic renal failure\n* known peripheral artery disease\n\nPatient after cardiac surgery:\n\nInclusion criteria:\n\n* ICU admission after coronary artery bypass grafting or valve surgery with cardiopulmonary bypass\n* General consent with admission at the University hospital\n\nExclusion criteria:\n\n* Age \\<18 or \\>80 years\n* known peripheral artery disease\n* no or only low dose of vasopressors (\\<300µg/h) at ICU admission\n* present or suspected myocardial ischemia\n* acute pulmonary embolism\n* known liver disease - Child-Pugh -Class B or C\n* known chronic renal failure\n\nHealthy volunteers:\n\nInclusion criteria:\n\n\\- Informed consent as documented by signature (Appendix Informed Consent Form)\n\nExclusion criteria:\n\n* Age \\<18 or \\>80 years\n* known peripheral artery disease'}, 'identificationModule': {'nctId': 'NCT02771002', 'acronym': 'CRTPPI', 'briefTitle': 'Assessment of Peripheral Perfusion in the Critically Ill Patient', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Evaluation of the Clinical Assessment of Peripheral Perfusion by Capillary Refill Time and Peripheral Perfusion Index', 'orgStudyIdInfo': {'id': 'CRTPPI 04/16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'septic shock patients', 'description': 'measurements of peripheral perfusion including capillary refill time, mottling score, temperature gradient and peripheral perfusion index hourly until normalisation of lactate sonographic assesment of perfusion of solid organs once within 24h after admission', 'interventionNames': ['Device: Peripheral Perfusion index by Carescape Patientenmonitor']}, {'label': 'patients rewarming after cardiac surgery', 'description': 'measurements of peripheral perfusion including capillary refill time, mottling score, temperature gradient and peripheral perfusion index hourly until extubation', 'interventionNames': ['Device: Peripheral Perfusion index by Carescape Patientenmonitor']}, {'label': 'healthy volunteers', 'description': 'measurements of peripheral perfusion including capillary refill time and peripheral perfusion index in ambient temperature and after cooling of extremity', 'interventionNames': ['Device: Peripheral Perfusion index by Carescape Patientenmonitor']}], 'interventions': [{'name': 'Peripheral Perfusion index by Carescape Patientenmonitor', 'type': 'DEVICE', 'description': 'Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor', 'armGroupLabels': ['healthy volunteers', 'patients rewarming after cardiac surgery', 'septic shock patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Bern University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}