Intra-abdominal Hypertension Clinical Trial
Official title:
Prospective, Interventional Multicentre Study on the Effect of Deepening of Sedation on Intra-abdominal Pressure
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Estonia | Tartu University Hospital | Tartu | Tartumaa |
Lead Sponsor | Collaborator |
---|---|
Tartu University Hospital |
Estonia,
Cheatham ML, Malbrain ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppäniemi 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. Epub 2007 Mar 22. — View Citation
Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppäniemi 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. Epub 2006 Sep 12. — View 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. — View 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. Epub 2004 Feb 3. — View 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. — View Citation
Rello J, Diaz E, Roque M, Vallés J. Risk factors for developing pneumonia within 48 hours of intubation. Am J Respir Crit Care Med. 1999 Jun;159(6):1742-6. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intra-abdominal pressure | At 30 minutes after the start of deepening of sedation (propofol bolus) | ||
Secondary | Intra-abdominal pressure | After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol | ||
Secondary | Richmond Agitation-Sedation Scale | After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol | ||
Secondary | Spontaneous and total respiratory rate | After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol | ||
Secondary | Tidal volume | After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol | ||
Secondary | PEEP, Ppeak, Pplat | After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol | ||
Secondary | Total number of vasopressor and inotrope boluses | From the beginning of the bolus injection of propofol until the end of the continuous infusion of propofol | During the intervention | |
Secondary | Maximal increase in dose of noradrenaline | From the beginning of the bolus injection of propofol until the end of the continuous infusion of propofol | During the intervention | |
Secondary | Mean arterial pressure | After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol | ||
Secondary | Abdominal perfusion pressure | After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol |
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