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

Purpose

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).

Condition	Intervention	Phase
Critically Ill Intra-Abdominal Hypertension Abdominal Compartment Syndrome Acute Kidney Injury	Procedure: CVVH Procedure: ultrafiltration Procedure: ultrafiltration control group	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

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 [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Difference between CVVH with fluid removal and CVVH without fluid removal [ Time Frame: after 24 hours and/or 7 days ] [ Designated as safety issue: Yes ]
Difference in terms of
- Need for vasopressor medication and hemodynamic parameters during the first seven days
- PaO2/FiO2 (worst value over 24h daily first 7 days)
- Volume of albumin solution or synthetic colloids administered during CVVH per 24h
- SOFA score daily first seven days
- Need for decompressive laparotomy or other means to decrease IAP
- Acid-base status
- Complications relating to ischemia
Difference between both groups in terms of daily fluid balance [ Time Frame: during 7 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Difference between both groups regarding recovery of renal function, need for RRT at discharge from the ICU and from the hospital [ Time Frame: discharge from ICU and hospital ] [ Designated as safety issue: No ]
Difference between both groups regarding mortality (28d, ICU and hospital) and ICU and hospital length of stay [ Time Frame: 28 days and length of stay in ICU and hospital ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2010
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CVVH with fluid removal	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.
Active Comparator: CVVH without fluid removal	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 control group ultrafiltration is set at 100 mL/h (and fluid administration is titrated to approach 100 mL /h)

Arms

Assigned Interventions

Experimental: CVVH with fluid removal

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.

Active Comparator: CVVH without fluid removal

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 control group

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077895

Contacts

Contact: Inneke De Laet, MD

inneke.delaet@zna.be

Locations

Belgium
ZNA Stuivenberg Hospital	Recruiting
Antwerp, Belgium
Contact: Inneke De Laet, MD inneke.delaet@zna.be
Principal Investigator: Inneke De Laet, MD
Sub-Investigator: Manu Malbrain, MD, PhD
University Hospital Ghent	Recruiting
Ghent, Belgium
Contact: Inneke De Laet, MD inneke.delaet@zna.be
Principal Investigator: Eric Hoste, MD, PhD
Sub-Investigator: Inneke De Laet, MD

Sponsors and Collaborators

University Hospital, Ghent

Stuivenberg Hospital Antwerp

Investigators

Principal Investigator:

Eric Hoste, MD, Phd

University Hospital Ghent, Belgium

More Information

Additional Information:

website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT01077895 History of Changes
Other Study ID Numbers:	2009/721
Study First Received:	February 25, 2010
Last Updated:	February 1, 2013
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:

Critically ill patients with positive fluid balance, IAH and AKI requiring RRT

Additional relevant MeSH terms:

Compartment Syndromes
Critical Illness
Hypertension
Acute Kidney Injury
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases

Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013