Critically IllPhase 3NCT01077895
The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function
A Phase 3 study testing CVVH and ultrafiltration in people with Critically Ill and Intra-Abdominal Hypertension, run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
- What is being tested?
- CVVH and ultrafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesBelgium
- Study dates
- Feb 2010to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
ZNA Stuivenberg Hospital
Antwerp
University Hospital Ghent
Ghent
About this study
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
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
- Being tested
- CVVH, ultrafiltration, ultrafiltration control group
- Keywords
- Critically ill patients with positive fluid balance, IAH and AKI requiring RRT
- Medical subject headings
- Critical Illness, Intra-Abdominal Hypertension, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVVHProcedure or surgery
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)
ultrafiltrationProcedure or surgery
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.
ultrafiltration control groupProcedure or surgery
ultrafiltration is set at 100 mL/h (and fluid administration is titrated to approach 100 mL /h)
| Study group | Role | What they receive |
|---|---|---|
| CVVH with fluid removal | Experimental | Not described Receives: Procedure: CVVH; Procedure: ultrafiltration |
| CVVH without fluid removal | Active comparator | Not described Receives: Procedure: CVVH; Procedure: ultrafiltration control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 and 48 hours
Secondary outcomes (5)
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
Measured: after 24 hours and/or 7 days
Difference between both groups in terms of daily fluid balance
Measured: 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
Measured: 24 hours
Difference between both groups regarding recovery of renal function, need for RRT at discharge from the ICU and from the hospital
Measured: discharge from ICU and hospital
Difference between both groups regarding mortality (28d, ICU and hospital) and ICU and hospital length of stay
Measured: 28 days and length of stay in ICU and hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Stuivenberg Hospital Antwerp
- Responsible party
- Sponsor
- Investigators
- Eric Hoste, MD, Phd, Principal investigator, University Hospital Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077895
- Sponsor's protocol ID
- 2009/721
- Status last verified
- Dec 2022
- First submitted
- 25 Feb 2010
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01077895
- Acronym / sponsor ID
- 2009/721
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Stuivenberg Hospital Antwerp
- Study start
- Feb 2010 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVVH with fluid removal | Experimental | Procedure: CVVH, Procedure: ultrafiltration |
| CVVH without fluid removal | Active comparator | Procedure: CVVH, Procedure: ultrafiltration control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVVHCVVH 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 or surgery | CVVH with fluid removal, CVVH without fluid removal |
| ultrafiltrationultra 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 or surgery | CVVH with fluid removal |
| ultrafiltration control groupultrafiltration is set at 100 mL/h (and fluid administration is titrated to approach 100 mL /h) | Procedure or surgery | CVVH without fluid removal |
Primary outcome
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
5 secondary outcomes
Difference between CVVH with fluid removal and CVVH without fluid removal
Time frame: after 24 hours and/or 7 days
Difference between both groups in terms of daily fluid balance
Time frame: 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
Time frame: 24 hours
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- website of the University Hospital GhentLink provided by the sponsor.
Related trials for Critically Ill
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hoste, MD, Phd principal investigator
University Hospital Ghent, Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CVVH and ultrafiltration in people with Critically Ill and Intra-Abdominal Hypertension, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.