Clinical Trial: Effect of Sedation on Intra-abdominal Pressure

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.

Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Tartu University Hospital

Dates:
Date Received: October 14, 2016
Date Started: November 2016
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016