Effect of Sedation on Intra-abdominal Pressure

Intra-abdominal Hypertension Clinical Trial

Official title:

Prospective, Interventional Multicentre Study on the Effect of Deepening of Sedation on Intra-abdominal Pressure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02944292
• Other study ID #: 16062
• Status: Recruiting
• Phase: Phase 4
• First received: October 14, 2016
• Last updated: December 6, 2017
• Start date: November 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: Tartu University Hospital
• Contact: Martin Padar, MD
• Phone: +372 5037911
• Email: martin.padar[@]kliinikum.ee
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

This is a prospective, interventional, multicentre study. There will be no control group.

Study subjects:

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 interventions to reduce IAP are planned.

Study intervention:

Sedation 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.

Series of measurements of IAP will be performed before (once) and after (repeatedly) intervention (deepening of sedation).

Deepness of sedation will be assessed with RASS score.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hypertension
• Intra-Abdominal Hypertension

Intervention

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

Drug:
• Propofol
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).

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu	Tartumaa

Sponsors (1)

Lead Sponsor	Collaborator
Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

References & Publications (7)

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

Outcome

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