Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02944292
Study type Interventional
Source Tartu University Hospital
Contact Martin Padar, MD
Phone +372 5037911
Email martin.padar@kliinikum.ee
Status Recruiting
Phase Phase 4
Start date November 2016
Completion date December 2018

See also
  Status Clinical Trial Phase
Completed NCT01507766 - The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis Phase 4
Completed NCT03567265 - Intra-abdominal Hypertension and Associated Factors Among Patients Admitted in Intensive Care Units in Uganda.
Completed NCT02543658 - Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension Phase 2
Completed NCT02514135 - Intra-abdominal Hypertension in Critically Ill Patients
Recruiting NCT01825304 - The Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation Phase 4
Not yet recruiting NCT03670771 - Intraabdominal Pressure in Critically Ill Patients
Not yet recruiting NCT03876418 - Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome N/A
Not yet recruiting NCT04286490 - Prone Position and Renal Resistive Index N/A
Completed NCT01355094 - Peritoneal Vacuum Therapy to Reduce Inflammatory Response From Abdominal Sepsis/Injury N/A
Not yet recruiting NCT02814734 - Abdominal Compartment Syndrome : Diagnostic and Prognostic Value of CT Findings - a Prospective Study N/A
Recruiting NCT04463745 - Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation
Completed NCT00747552 - Intra-Abdominal Hypertension in Neonatal Intensive Care Patients N/A
Completed NCT05732545 - Application of Enteral Nutrition Program in Patients With Intra-abdominal Hypertension Oriented by Intra-abdominal Pressure N/A
Enrolling by invitation NCT05070572 - Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output
Completed NCT04481880 - Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity
Recruiting NCT01072071 - The Influence of Furosemide on Fluid Balance and Intra-abdominal Pressure in Critically Ill Patients N/A
Withdrawn NCT01077895 - The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function Phase 3
Recruiting NCT06333366 - First-In-Human Study of PDT to Detect IAH N/A
Completed NCT04525027 - Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis
Not yet recruiting NCT06160856 - Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.