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).

Study Overview

• Status: Withdrawn
• Conditions: Acute Kidney Injury; Intra-Abdominal Hypertension; Critically Ill; Abdominal Compartment Syndrome
• Intervention / Treatment: Procedure: CVVH; Procedure: ultrafiltration; Procedure: ultrafiltration control group

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • ZNA Stuivenberg Hospital
  • Ghent, Belgium
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	24 and 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	after 24 hours and/or 7 days
Difference between both groups in terms of daily fluid balance		during 7 days
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		24 hours
Difference between both groups regarding recovery of renal function, need for RRT at discharge from the ICU and from the hospital		discharge from ICU and hospital
Difference between both groups regarding mortality (28d, ICU and hospital) and ICU and hospital length of stay		28 days and length of stay in ICU and hospital

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Stuivenberg Hospital Antwerp
• Investigators: Principal Investigator: Eric Hoste, MD, Phd, University Hospital Ghent, Belgium

Publications and helpful links

Helpful Links

• Website of the University Hospital Ghent

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 26, 2010
• First Posted (Estimate): March 1, 2010

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Critically ill patients with positive fluid balance, IAH and AKI requiring RRT
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Musculoskeletal Diseases; Muscular Diseases; Hypertension; Critical Illness; Acute Kidney Injury; Compartment Syndromes; Intra-Abdominal Hypertension
• Other Study ID Numbers: 2009/721