Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
Study NCT ID:
NCT02944292
Status:
UNKNOWN
Last Update Posted:
2017-12-08
First Post:
2016-10-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Sedation on Intra-abdominal Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}], 'ancestors': [{'id': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-06', 'studyFirstSubmitDate': '2016-10-14', 'studyFirstSubmitQcDate': '2016-10-23', 'lastUpdatePostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-abdominal pressure', 'timeFrame': 'At 30 minutes after the start of deepening of sedation (propofol bolus)'}], 'secondaryOutcomes': [{'measure': 'Intra-abdominal pressure', 'timeFrame': 'After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol'}, {'measure': 'Richmond Agitation-Sedation Scale', 'timeFrame': 'After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol'}, {'measure': 'Spontaneous and total respiratory rate', 'timeFrame': 'After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol'}, {'measure': 'Tidal volume', 'timeFrame': 'After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol'}, {'measure': 'PEEP, Ppeak, Pplat', 'timeFrame': 'After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol'}, {'measure': 'Total number of vasopressor and inotrope boluses', 'timeFrame': 'During the intervention', 'description': 'From the beginning of the bolus injection of propofol until the end of the continuous infusion of propofol'}, {'measure': 'Maximal increase in dose of noradrenaline', 'timeFrame': 'During the intervention', 'description': 'From the beginning of the bolus injection of propofol until the end of the continuous infusion of propofol'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol'}, {'measure': 'Abdominal perfusion pressure', 'timeFrame': 'After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intra-abdominal pressure', 'Intra-abdominal hypertension'], 'conditions': ['Intra-abdominal Hypertension']}, 'referencesModule': {'availIpds': [{'url': 'https://drive.google.com/open?id=0B-XpW352z4ZJMFdseHNwTWI2clU', 'type': 'Study Protocol'}], 'references': [{'pmid': '14758472', 'type': 'BACKGROUND', 'citation': 'Malbrain ML, Chiumello D, Pelosi P, Wilmer A, Brienza N, Malcangi V, Bihari D, Innes R, Cohen J, Singer P, Japiassu A, Kurtop E, De Keulenaer BL, Daelemans R, Del Turco M, Cosimini P, Ranieri M, Jacquet L, Laterre PF, Gattinoni L. Prevalence of intra-abdominal hypertension in critically ill patients: a multicentre epidemiological study. Intensive Care Med. 2004 May;30(5):822-9. doi: 10.1007/s00134-004-2169-9. Epub 2004 Feb 3.'}, {'pmid': '15699833', 'type': 'BACKGROUND', 'citation': 'Malbrain ML, Chiumello D, Pelosi P, Bihari D, Innes R, Ranieri VM, Del Turco M, Wilmer A, Brienza N, Malcangi V, Cohen J, Japiassu A, De Keulenaer BL, Daelemans R, Jacquet L, Laterre PF, Frank G, de Souza P, Cesana B, Gattinoni L. Incidence and prognosis of intraabdominal hypertension in a mixed population of critically ill patients: a multiple-center epidemiological study. Crit Care Med. 2005 Feb;33(2):315-22. doi: 10.1097/01.ccm.0000153408.09806.1b.'}, {'pmid': '18446319', 'type': 'BACKGROUND', 'citation': 'Reintam A, Parm P, Kitus R, Kern H, Starkopf J. Primary and secondary intra-abdominal hypertension--different impact on ICU outcome. Intensive Care Med. 2008 Sep;34(9):1624-31. doi: 10.1007/s00134-008-1134-4. Epub 2008 May 1.'}, {'pmid': '17377769', 'type': 'BACKGROUND', 'citation': "Cheatham ML, Malbrain ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, D'Amours S, Wendon J, Hillman K, Wilmer A. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. II. Recommendations. Intensive Care Med. 2007 Jun;33(6):951-62. doi: 10.1007/s00134-007-0592-4. Epub 2007 Mar 22."}, {'pmid': '19602975', 'type': 'BACKGROUND', 'citation': 'Treggiari MM, Romand JA, Yanez ND, Deem SA, Goldberg J, Hudson L, Heidegger CP, Weiss NS. Randomized trial of light versus deep sedation on mental health after critical illness. Crit Care Med. 2009 Sep;37(9):2527-34. doi: 10.1097/CCM.0b013e3181a5689f.'}, {'pmid': '10351912', 'type': 'BACKGROUND', 'citation': 'Rello J, Diaz E, Roque M, Valles J. Risk factors for developing pneumonia within 48 hours of intubation. Am J Respir Crit Care Med. 1999 Jun;159(6):1742-6. doi: 10.1164/ajrccm.159.6.9808030.'}, {'pmid': '16967294', 'type': 'BACKGROUND', 'citation': "Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, D'Amours S, Wendon J, Hillman K, Johansson K, Kolkman K, Wilmer A. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. I. Definitions. Intensive Care Med. 2006 Nov;32(11):1722-32. doi: 10.1007/s00134-006-0349-5. Epub 2006 Sep 12."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of deepening of sedation on intra-abdominal pressure in mechanically ventilated adult patients with intra-abdominal hypertension.', 'detailedDescription': "The importance of intra-abdominal pressure (IAP) in critically ill patients has been addressed increasingly. Several studies have shown that elevated mean IAP is associated with adverse ICU outcomes. The prevalence of intra-abdominal hypertension (IAH) among critically ill patients is as high as 50% if defined according to maximal IAP and half of it if defined according to mean IAP. Development of IAH during ICU period is an independent risk factor for death. Considering such significant impact on patients' outcome, international conference of experts has agreed and published recommendations for treatment of IAH and abdominal compartment syndrome. Among others, deepening of sedation is suggested as treatment option. The recommendation is based on expert opinion; there are no controlled clinical studies available to support this approach. Importantly, recent studies have shown that deep sedation itself may be associated with worse outcome to patients. Treggiari et al suggest that a strategy of light sedation affords benefits with regard to reduction of intensive care unit stay and duration of ventilation without negatively affecting subsequent patient mental health or patient safety. Others have shown reduced ICU mortality as well as reduced incidence of ventilator-associated pneumonia in conjunction with light sedation.\n\nThis is a prospective, interventional, multicentre study. There will be no control group.\n\nStudy subjects:\n\nAdult, mechanically ventilated patients with IAP between 12 and 20 mmHg in at least two consecutive measurements, spontaneous breathing activity of at least 6 breaths/minute, RASS score between 0 and -4, if no contraindications to propofol administration are present and no other interventions to reduce IAP are planned.\n\nStudy intervention:\n\nSedation deepening will be achieved with a bolus of propofol 1 mg/kg followed by continuous infusion of propofol 3 mg/kg/h for one hour. Patients previously receiving propofol infusion will receive supplemental propofol per protocol up to a maximum infusion rate of 5 mg/kg/h.\n\nSeries of measurements of IAP will be performed before (once) and after (repeatedly) intervention (deepening of sedation).\n\nDeepness of sedation will be assessed with RASS score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Mechanical ventilation\n* IAP between 12 and 20 mmHg in at least two consecutive measurements within 1-12 h\n* Spontaneous breathing activity of at least 6 breaths/minute\n* RASS score between 0 and -4\n* Physician-led sedation (if sedated; as opposed to nurse-led protocol)\n\nExclusion Criteria:\n\n* Contraindication for propofol administration\n* Contraindication for IAP measurement in supine position with head-of-bed at 0°\n* Other intervention for reduction of IAP planned\n* Previous propofol infusion rate \\>4 mg/kg/h'}, 'identificationModule': {'nctId': 'NCT02944292', 'briefTitle': 'Effect of Sedation on Intra-abdominal Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Tartu University Hospital'}, 'officialTitle': 'Prospective, Interventional Multicentre Study on the Effect of Deepening of Sedation on Intra-abdominal Pressure', 'orgStudyIdInfo': {'id': '16062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All enrolled patients', 'description': 'Study population:\n\nAdult, mechanically ventilated patients with IAP between 12 and 20 mmHg in at least two consecutive measurements, spontaneous breathing activity of at least 6 breaths/minute, RASS score between 0 and -4, if no contraindications to propofol administration are present and no other immediate interventions to reduce IAP are planned\n\nIntervention: Deepening of sedation Deepening of sedation will be achieved with a bolus of propofol followed by continuous infusion for one hour.', 'interventionNames': ['Procedure: Deepening of sedation', 'Drug: Propofol']}], 'interventions': [{'name': 'Deepening of sedation', 'type': 'PROCEDURE', 'description': 'Deepening of sedation will be achieved with a bolus and subsequent continuous infusion of propofol.', 'armGroupLabels': ['All enrolled patients']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol will be dosed according to lean body weight (LBW) for bolus administration and according to total body weight (TBW) for continuous infusion.\n\nAll patients will receive a bolus of propofol 1 mg/kg LBW as a rapid infusion during one minute. Measurements will be made one minute after the ending of bolus infusion. Continuous infusion of propofol at a rate of 3 mg/kg/h will be started immediately following completion of measurements, not later than 5 minutes after bolus administration. The propofol infusion rate is decreased in case of hemodynamic instability by 1 mg/kg/h and until a minimum of 1 mg/kg/h, if needed. Maximum total dose of infusion of 5 mg/kg/h will not be exceeded (bolus not considered).', 'armGroupLabels': ['All enrolled patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51014', 'city': 'Tartu', 'state': 'Tartu', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Martin Padar, MD', 'role': 'CONTACT', 'email': 'martin.padar@kliinikum.ee', 'phone': '+3725037911'}, {'name': 'Joel Starkopf, Professor, MD, PhD', 'role': 'CONTACT', 'email': 'joel.starkopf@kliinikum.ee'}], 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'centralContacts': [{'name': 'Martin Padar, MD', 'role': 'CONTACT', 'email': 'martin.padar@kliinikum.ee', 'phone': '+372 5037911'}, {'name': 'Joel Starkopf, MD PhD', 'role': 'CONTACT', 'email': 'joel.starkopf@kliinikum.ee', 'phone': '+372 731 8400'}], 'overallOfficials': [{'name': 'Joel Starkopf, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tartu University Hospital; University of Tartu'}, {'name': 'Annika Reintam Blaser, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Tartu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tartu University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anaesthesiology and Intensive Care', 'investigatorFullName': 'Joel Starkopf', 'investigatorAffiliation': 'Tartu University Hospital'}}}}