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

NCT01077895 | Withdrawn Phase 3

• 1 other identifier: 2009/721
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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).

Conditions

Critically Ill; Intra-Abdominal Hypertension; Abdominal Compartment Syndrome; Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (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

  24 and 48 hours

Secondary Outcomes (5)

• Difference between CVVH with fluid removal and CVVH without fluid removal

  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

Study Arms (2)

CVVH with fluid removal

EXPERIMENTAL

Procedure: CVVH; Procedure: ultrafiltration

CVVH without fluid removal

ACTIVE COMPARATOR

Procedure: CVVH; Procedure: ultrafiltration control group

Interventions

CVVH PROCEDURE

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)

CVVH with fluid removal; CVVH without fluid removal

ultrafiltration PROCEDURE

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.

CVVH with fluid removal

ultrafiltration control group PROCEDURE

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

CVVH without fluid removal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Stuivenberg Hospital Antwerp: collaborator

Study Sites (2)

ZNA Stuivenberg Hospital

Antwerp, Belgium

Location

University Hospital Ghent

Ghent, Belgium

Location

Related Links

• website of the University Hospital Ghent

MeSH Terms

Conditions

Critical Illness; Intra-Abdominal Hypertension; Acute Kidney Injury

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Study Officials

• Eric Hoste, MD, Phd

  University Hospital Ghent, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (2)