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

Primary Purpose

Critically Ill, Intra-Abdominal Hypertension, Abdominal Compartment Syndrome

Status
Withdrawn
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
CVVH
ultrafiltration
ultrafiltration control group
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring Critically ill patients with positive fluid balance, IAH and AKI requiring RRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ZNA Stuivenberg Hospital
  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CVVH with fluid removal

CVVH without fluid removal

Arm Description

Outcomes

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

Secondary Outcome Measures

Difference between CVVH with fluid removal and CVVH without fluid removal
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
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
Difference between both groups regarding recovery of renal function, need for RRT at discharge from the ICU and from the hospital
Difference between both groups regarding mortality (28d, ICU and hospital) and ICU and hospital length of stay

Full Information

First Posted
February 25, 2010
Last Updated
December 14, 2022
Sponsor
University Hospital, Ghent
Collaborators
Stuivenberg Hospital Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT01077895
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Study Start Date
February 2010 (Actual)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Stuivenberg Hospital Antwerp

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Intra-Abdominal Hypertension, Abdominal Compartment Syndrome, Acute Kidney Injury
Keywords
Critically ill patients with positive fluid balance, IAH and AKI requiring RRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CVVH with fluid removal
Arm Type
Experimental
Arm Title
CVVH without fluid removal
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
CVVH
Intervention Description
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
Intervention Name(s)
ultrafiltration
Intervention Description
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
Intervention Name(s)
ultrafiltration control group
Intervention Description
ultrafiltration is set at 100 mL/h (and fluid administration is titrated to approach 100 mL /h)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Difference between CVVH with fluid removal and CVVH without fluid removal
Description
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
Time Frame
after 24 hours and/or 7 days
Title
Difference between both groups in terms of daily fluid balance
Time Frame
during 7 days
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Hoste, MD, Phd
Organizational Affiliation
University Hospital Ghent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZNA Stuivenberg Hospital
City
Antwerp
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website of the University Hospital Ghent

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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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