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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Stuivenberg Hospital Antwerp
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01077895
First received: February 25, 2010
Last updated: February 1, 2013
Last verified: February 2013

February 25, 2010
February 1, 2013
February 2010
December 2013   (final data collection date for primary outcome 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 [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01077895 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Critically Ill
  • Intra-Abdominal Hypertension
  • Abdominal Compartment Syndrome
  • Acute Kidney Injury
  • 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.
  • Procedure: ultrafiltration control group
    ultrafiltration is set at 100 mL/h (and fluid administration is titrated to approach 100 mL /h)
  • Experimental: CVVH with fluid removal
    Interventions:
    • Procedure: CVVH
    • Procedure: ultrafiltration
  • Active Comparator: CVVH without fluid removal
    Interventions:
    • Procedure: CVVH
    • Procedure: ultrafiltration control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
March 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Inneke De Laet, MD inneke.delaet@zna.be
Belgium
 
NCT01077895
2009/721
No
University Hospital, Ghent
University Hospital, Ghent
Stuivenberg Hospital Antwerp
Principal Investigator: Eric Hoste, MD, Phd University Hospital Ghent, Belgium
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP