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

NCT ID: NCT01077895

Last Updated: 2022-12-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-12-31

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CVVH with fluid removal

Group Type: EXPERIMENTAL

CVVH

Intervention Type: PROCEDURE

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)

ultrafiltration

Intervention Type: PROCEDURE

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.

CVVH without fluid removal

Group Type: ACTIVE_COMPARATOR

CVVH

Intervention Type: PROCEDURE

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)

ultrafiltration control group

Intervention Type: PROCEDURE

ultrafiltration is set at 100 mL/h (and fluid administration is titrated to approach 100 mL /h)

Interventions

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)

Intervention Type: 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.

Intervention Type: PROCEDURE

ultrafiltration control group

ultrafiltration is set at 100 mL/h (and fluid administration is titrated to approach 100 mL /h)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stuivenberg Hospital Antwerp

UNKNOWN

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Hoste, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ghent, Belgium

Locations

ZNA Stuivenberg Hospital

Antwerp, , Belgium

University Hospital Ghent

Ghent, , Belgium

Countries

Belgium

Related Links

http://www.uzgent.be

website of the University Hospital Ghent

Other Identifiers

2009/721

Identifier Type: -

Identifier Source: org_study_id