Clinical trial NCT01077895: The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Critically Ill
Intra-Abdominal Hypertension
Abdominal Compartment Syndrome
Acute Kidney Injury
Keywords: Critically ill patients with positive fluid balance, IAH and AKI requiring RRT
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Stuivenberg Hospital Antwerp
First posted: 2010-03-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in IAP in patients receiving fluid removal during CVVH vs patients receiving CVVH without net fluid removal after 24 and 48h of CVVH treatment
timeFrame: 24 and 48 hours
Secondary outcomes:
measure: Difference between CVVH with fluid removal and CVVH without fluid removal
timeFrame: after 24 hours and/or 7 days
measure: Difference between both groups in terms of daily fluid balance
timeFrame: during 7 days
measure: The relationship between cumulative fluid balance at the start of each day of CVVH and the fluid balance achieved after 24h of CVVH with fluid removal
timeFrame: 24 hours
measure: Difference between both groups regarding recovery of renal function, need for RRT at discharge from the ICU and from the hospital
timeFrame: discharge from ICU and hospital
measure: Difference between both groups regarding mortality (28d, ICU and hospital) and ICU and hospital length of stay
timeFrame: 28 days and length of stay in ICU and hospital
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: ZNA Stuivenberg Hospital
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital Ghent, Belgium
name: Eric Hoste, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: