NCT01077895

The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function

The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function in Critically Ill Adults With Intra-abdominal Hypertension and Acute Kidney Injury

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intra- abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) are a cause of organ dysfunction in critically ill patients. IAH develops due to abdominal lesions (primary IAH) or extra-abdominal processes (secondary IAH). Secondary IAH arises due to decreased abdominal wall compliance and gut edema caused by capillary leak and excessive fluid resuscitation. Decreasing intra-abdominal pressure (IAP) using decompressieve laparotomy has been shown to improve organ dysfunction. However, laparotomy is generally avoided in patients with secondary IAH due to the risk of abdominal complications. Acute kidney injury (AKI) is one of the first and most pronounced organ failures associated with IAH and many patients with AKI in the ICU require renal replacement therapy (RRT). Fluid removal using continuous RRT (CRRT) has been demonstrated to decrease IAP in small series and selected patients. The aim of this study is to evaluate whether fluid removal using CVVH in patients with IAH, fluid overload and AKI is feasible and whether it has a beneficial effect on organ dysfunction (compared to CVVH without net fluid removal).

Conditions

• Critically Ill
• Intra-Abdominal Hypertension
• Abdominal Compartment Syndrome
• Acute Kidney Injury

Interventions

Type	Name	Description
PROCEDURE	CVVH	CVVH is started using following parameters: * Blood flow is started at 150 mL/min * Anticoagulation: none, heparin or low molecular weight heparin according to local protocols in study centers. * In both groups: dialysis dose of 25 mL/kg body weight administered using both pre- and postdilution * Substitution fluid temperature is started at 37°C and adjusted in function of patient body temperature (which is maintained at 35-37°C)
PROCEDURE	ultrafiltration	ultra filtration is started at 100 mL/h and increased according to following protocol * Ultrafiltration is increased by 100 mL/h after 2h and subsequently by 100mL/h (until a maximum of 500mL/h) every 4h unless: * Vasopressor or inotrope medication dose is increased by \> 25% (provided mean arterial pressure remains constant at 65 mmHg or another target value specified by treating physician according to standard of care) * When above condition is not met UF should be kept constant and a passive leg raising test or stroke volume variation measurement should be performed. If SVV \> 10% or PLR is positive 100mL of albumin 20% solution or 250 mL of Hydroxyethyl Starch 130/0.4 solution is administered according to treating physician at a maximum of 4 times per 24h * If there is no improvement after 2 colloid administration rounds, UF should be stopped for 4h and restarted at half the rate it was set at when discontinued.
PROCEDURE	ultrafiltration control group	ultrafiltration is set at 100 mL/h (and fluid administration is titrated to approach 100 mL /h)

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-03-01
• Last updated: 2022-12-15

Locations

2 sites across 1 country: Belgium