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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

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.

Condition or disease Intervention/treatment Phase
Intra-abdominal Hypertension Procedure: Deepening of sedation Drug: Propofol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Interventional Multicentre Study on the Effect of Deepening of Sedation on Intra-abdominal Pressure
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
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.

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).





Primary Outcome Measures :
  1. Intra-abdominal pressure [ Time Frame: At 30 minutes after the start of deepening of sedation (propofol bolus) ]

Secondary Outcome Measures :
  1. Intra-abdominal pressure [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  2. Richmond Agitation-Sedation Scale [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  3. 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 ]
  4. Tidal volume [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  5. PEEP, Ppeak, Pplat [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  6. 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

  7. 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

  8. Mean arterial pressure [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]
  9. Abdominal perfusion pressure [ Time Frame: After sedative bolus; at 1) 15, 2) 30, 3) 60 minutes after starting the continuous infusion of propofol ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944292


Contacts
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Contact: Martin Padar, MD +372 5037911 martin.padar@kliinikum.ee
Contact: Joel Starkopf, MD PhD +372 731 8400 joel.starkopf@kliinikum.ee

Locations
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Estonia
Tartu University Hospital Recruiting
Tartu, Tartumaa, Estonia, 51014
Contact: Martin Padar, MD    +3725037911    martin.padar@kliinikum.ee   
Contact: Joel Starkopf, Professor, MD, PhD       joel.starkopf@kliinikum.ee   
Sponsors and Collaborators
Tartu University Hospital
Investigators
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Study Director: Joel Starkopf, MD PhD Tartu University Hospital; University of Tartu
Study Director: Annika Reintam Blaser, MD PhD University of Tartu
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Joel Starkopf, Professor of Anaesthesiology and Intensive Care, Tartu University Hospital
ClinicalTrials.gov Identifier: NCT02944292    
Other Study ID Numbers: 16062
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joel Starkopf, Tartu University Hospital:
Intra-abdominal pressure
Intra-abdominal hypertension
Additional relevant MeSH terms:
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Intra-Abdominal Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics