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Effect of Sedation on Intra-abdominal Pressure

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ClinicalTrials.gov Identifier: NCT02944292
Recruitment Status : Unknown
Verified December 2017 by Joel Starkopf, Tartu University Hospital.
Recruitment status was:  Recruiting
First Posted : October 25, 2016
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Joel Starkopf, Tartu University Hospital

Tracking Information
First Submitted Date  ICMJE October 14, 2016
First Posted Date  ICMJE October 25, 2016
Last Update Posted Date December 8, 2017
Actual Study Start Date  ICMJE November 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2016)
Intra-abdominal pressure [ Time Frame: At 30 minutes after the start of deepening of sedation (propofol bolus) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2016)
  • Intra-abdominal pressure [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  • Richmond Agitation-Sedation Scale [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  • Spontaneous and total respiratory rate [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  • Tidal volume [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  • PEEP, Ppeak, Pplat [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  • Total number of vasopressor and inotrope boluses [ Time Frame: During the intervention ]
    From the beginning of the bolus injection of propofol until the end of the continuous infusion of propofol
  • Maximal increase in dose of noradrenaline [ Time Frame: During the intervention ]
    From the beginning of the bolus injection of propofol until the end of the continuous infusion of propofol
  • Mean arterial pressure [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  • Abdominal perfusion pressure [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Sedation on Intra-abdominal Pressure
Official Title  ICMJE Prospective, Interventional Multicentre Study on the Effect of Deepening of Sedation on Intra-abdominal Pressure
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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intra-abdominal Hypertension
Intervention  ICMJE
  • 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).

Study Arms  ICMJE Experimental: All enrolled patients

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.

Interventions:
  • Procedure: Deepening of sedation
  • Drug: Propofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02944292
Other Study ID Numbers  ICMJE 16062
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joel Starkopf, Tartu University Hospital
Study Sponsor  ICMJE Tartu University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joel Starkopf, MD PhD Tartu University Hospital; University of Tartu
Study Director: Annika Reintam Blaser, MD PhD University of Tartu
PRS Account Tartu University Hospital
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP