Effect of Sedation on Intra-abdominal Pressure

NCT02944292 | Unknown Phase 4

• 1 other identifier: 16062
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intra-abdominal Hypertension

Keywords

Intra-abdominal pressure; Intra-abdominal hypertension

Outcome Measures

Primary Outcomes (1)

• Intra-abdominal pressure

  At 30 minutes after the start of deepening of sedation (propofol bolus)

Secondary Outcomes (9)

• Intra-abdominal pressure

  After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol

• Richmond Agitation-Sedation Scale

  After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol

• Spontaneous and total respiratory rate

  After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol

• Tidal volume

  After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol

• PEEP, Ppeak, Pplat

  After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol

Study Arms (1)

All enrolled patients

EXPERIMENTAL

Study population: Adult, 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 Intervention: Deepening of sedation Deepening of sedation will be achieved with a bolus of propofol followed by continuous infusion for one hour.

Procedure: Deepening of sedation; Drug: Propofol

Interventions

Deepening of sedation PROCEDURE

Deepening of sedation will be achieved with a bolus and subsequent continuous infusion of propofol.

All enrolled patients

Propofol DRUG

Propofol will be dosed according to lean body weight (LBW) for bolus administration and according to total body weight (TBW) for continuous infusion. All 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).

All enrolled patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Mechanical ventilation
• IAP between 12 and 20 mmHg in at least two consecutive measurements within 1-12 h
• Spontaneous breathing activity of at least 6 breaths/minute
• RASS score between 0 and -4
• Physician-led sedation (if sedated; as opposed to nurse-led protocol)

You may not qualify if:

• Contraindication for propofol administration
• Contraindication for IAP measurement in supine position with head-of-bed at 0°
• Other intervention for reduction of IAP planned
• Previous propofol infusion rate \>4 mg/kg/h

Sponsors & Collaborators

• Tartu University Hospital: lead

Study Sites (1)

Tartu University Hospital

Tartu, Tartu, 51014, Estonia

RECRUITING

Related Publications (7)

• 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: 14758472 BACKGROUND

• 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: 15699833 BACKGROUND

• 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: 18446319 BACKGROUND

• 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: 17377769 BACKGROUND

• 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: 19602975 BACKGROUND

• 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: 10351912 BACKGROUND

• 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.

  PMID: 16967294 BACKGROUND

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Interventions

Propofol

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Joel Starkopf, MD PhD

  Tartu University Hospital; University of Tartu

  STUDY DIRECTOR

• Annika Reintam Blaser, MD PhD

  University of Tartu

  STUDY DIRECTOR

Central Study Contacts

Martin Padar, MD

CONTACT

+372 5037911; martin.padar@kliinikum.ee

Joel Starkopf, MD PhD

CONTACT

+372 731 8400; joel.starkopf@kliinikum.ee

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesiology and Intensive Care

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 25, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)