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

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ClinicalTrials.gov Identifier: NCT01077895
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : March 1, 2010
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Stuivenberg Hospital Antwerp
Information provided by (Responsible Party):
University Hospital, Ghent

Study Description
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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).


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : February 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Difference between CVVH with fluid removal and CVVH without fluid removal [ Time Frame: after 24 hours and/or 7 days ]

    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

  2. Difference between both groups in terms of daily fluid balance [ Time Frame: during 7 days ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077895


Contacts
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Contact: Inneke De Laet, MD inneke.delaet@zna.be

Locations
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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
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Principal Investigator: Eric Hoste, MD, Phd University Hospital Ghent, Belgium
More Information
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Additional Information:

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01077895    
Other Study ID Numbers: 2009/721
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Keywords provided by University Hospital, Ghent:
Critically ill patients with positive fluid balance, IAH and AKI requiring RRT
Additional relevant MeSH terms:
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Compartment Syndromes
Intra-Abdominal Hypertension
Acute Kidney Injury
Hypertension
Critical Illness
Vascular Diseases
Cardiovascular Diseases
 Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Muscular Diseases
Musculoskeletal Diseases