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

Ghent University Hospital (UZ)

Status and phase: Withdrawn; Phase 3

Conditions: Critically Ill; Acute Kidney Injury; Abdominal Compartment Syndrome; Intra-Abdominal Hypertension

Treatments: Procedure: ultrafiltration; Procedure: ultrafiltration control group; Procedure: CVVH

Study type: Interventional

Funder types: Other

Identifiers

NCT01077895

2009/721

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (>18y old) of either gender
• Admitted to the ICU
• Sedated and mechanically ventilated (and expected to remain so for at least 48h)
• Informed consent given
• admitted to the ICU for <7 days or during the first 7 days of a new shock episode
• AKI requiring RRT according to treating physician
• IAP >12mmHg being attributed to fluid overload by treating physician

Exclusion criteria

• Included in the same study before
• Vasopressor and/or inotrope dose needed above noradrenaline 1µg/kg/min and dobutamine 10µg/kg/min
• PaO2/FiO2 ratio <100

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

CVVH with fluid removal

Experimental group

Treatment:

Procedure: CVVH

Procedure: ultrafiltration

CVVH without fluid removal

Active Comparator group

Treatment:

Procedure: CVVH

Procedure: ultrafiltration control group