Liver SurgeryNCT04092608
Restrictive vs Goal Directed Fluid Therapy During Hepatobiliary Surgery
A study testing GDFT and LOW CVP (restrictive group) in people with Liver Surgery, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
"Restrictive" fluid management is usually the current standard practice for patients undergoing liver surgery. The general idea is to maintain a low central venous pressure in order to decrease blood loss and improve the quality of the surgical field. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Liver Surgery
- What is being tested?
- GDFT and LOW CVP (restrictive group)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Sep 2019to 30 Jul 2020
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -All adults patients undergoing a liver surgery and equipped with a cardiac output monitoring device
Who cannot join
- -Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Goal-directed Versus Restrictive Fluid Therapy on Urethral Tissue Perfusion in Hepatobiliary Surgery: A Prospective Randomized Controlled Trial
"Restrictive" fluid management is usually the current standard practice for patients undergoing liver surgery. The general idea is to maintain a low central venous pressure in order to decrease blood loss and improve the quality of the surgical field. However, this strategy , considered as rather "restrictive", can be associated with patient's harm, mainly acute kidney injury.
Today, Goal directed fluid therapy (GDFT) is a well accepted strategy to optimize fluid administration in patients undergoing major surgery which aimed to maintain normovolemia without being too liberal.
The goal of this randomized controlled trial is to compare these two strategies on Urethral Perfusion index measured with a new IKORUS UP probe (Foley catheter made smarter with embedded photoplethysmographic sensing technology).
Read the detailed description
Restrictive fluid administration aiming at maintaining a low central venous pressure (low-CVP) during liver surgery has always been considered as a "gold standard" strategy because it decrease blood loss and improve the quality of the surgical field. However, this strategy , rather "restrictive", can be associated with patient harm (mainly AKI).
Today, Goal directed fluid therapy (GDFT) is a well accepted strategy to optimize fluid administration in patients undergoing major surgery.Some studies have shown that this strategy is feasible for such patient population.
There is currently a lack of data supporting the advantage of one strategy over the other in this patient population.While a restrictive fluid strategy can advantage the surgeon, it can also disadvantage the patient as in order to avoid hypotension, vasopressors administration is required. If the patient is hypovolemic, such strategy may cause acute kidney injury.
The goal of this randomized controlled trial is to compare these two strategies on Urethral Perfusion index measured with a new Foley catheter with embedded photoplethysmographic sensing technology). This new technology allows for continuous and easy monitoring of urethral tissue perfusion
The investigators hypothesis is that patients in the GDFT group will have better Urethral Perfusion index (uPI) during surgery (via a better cardiac blood flow optimization) compared to patients in the restrictive (low CVP) group.
- Conditions
- Liver Surgery
- Being tested
- GDFT, LOW CVP (restrictive group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDFTProcedure or surgery
The titration of fluid will be based on stroke volume variation. The goal is to maintain this variable < 13% during surgery with multiple mini fluid challenge of 100 ml of balanced crystalloid.
LOW CVP (restrictive group)Procedure or surgery
Goal = CVP < 7mmHg and only 2 ml/kg/h max during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Low CVP group (restrictive group) | Active comparator | Standard practice: the goal is to keep the CVP < 7 mmHg during surgery.
Baseline of crystalloid of 2ml/kg/h max in all patients.
EV 1000 monitoring device (Edwards Lifesciences, Irvine, USA) will be used but values will be blinded to the anesthesiologist in charge of the patient.
Mean Arterial pressure (MAP) should be kept over 65mmHg during surgery (standard practice) with continuous norepinephrine infusion
Additionnal fluid administration is given to the patient at the end of the surgery (standard practice)
UPi is blinded in all groups Receives: Procedure: LOW CVP (restrictive group) |
| GDFT group | Experimental | The goal is to keep stroke volume variation below 13% during surgery with mini fluid challenge of 100 ml of balanced crystalloid using the monitoring device (Edwards Lifesciences, Irvine, USA). Of course, the values will not be blinded to the anesthesiologist in charge of the patient.
All patients have a baseline crystalloid: 2ml/kg/h and mini fluid challenges per 100 ml as described above.
Mean Arterial pressure (MAP) should be kept over 65mmHg during surgery (standard practice) with continuous norepinephrine infusion
UPi is blinded in all groups Receives: Procedure: GDFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethral Perfusion index
average of the Urethral Perfusion index values
Measured: during surgery
Secondary outcomes (10)
Urethral Perfusion index
average of the Urethral Perfusion index values during the first 15-30 minutes of the surgery
Measured: during surgery
Urethral Perfusion index
average of the Urethral Perfusion index values during the last 15-30 minutes of the surgery
Measured: during surgery
Amount of fluid during surgery
amount of crystalloid received during the surgery
Measured: during surgery
Amount of vasopressors
amount of vasopressors received during surgery
Measured: during surgery
Stroke volume index
average of stroke volume index during surgery
Measured: during surgery
stroke volume variation
average of stroke volume variation during surgery
Measured: during surgery
cardiac index
average of cardiac index during surgery
Measured: during surgery
incidence of acute kidney injury
incidence of acute kidney injury measured with the KDIGO classification
Measured: At postoperative day 7
length of stay in the hospital
length of stay in the hospital
Measured: Postoperative day 30
Incidence of postoperative complications
Incidence of postoperative complications
Measured: Postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start4 Sep 2019
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver SurgeryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center randomized controlled superiority study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bicetre Hospital
- Responsible party
- Principal investigator, Alexandre Joosten, MD PhD, Erasme University Hospital
- Investigators
- Alexandre Joosten, MD PhD, Principal investigator, ERASME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092608
- Sponsor's protocol ID
- B406201940521
- Status last verified
- Aug 2020
- First submitted
- 12 Sep 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chirnoaga D, Coeckelenbergh S, Ickx B, Van Obbergh L, Lucidi V, Desebbe O, Carrier FM, Michard F, Vincent JL, Duranteau J, Van der Linden P, Joosten A. Impact of conventional vs. goal-directed fluid therapy on urethral tissue perfusion in patients undergoing liver surgery: A pilot randomised controlled trial. Eur J Anaesthesiol. 2022 Apr 1;39(4):324-332. doi: 10.1097/EJA.0000000000001615.
PubMed 34669645
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Goal-directed Versus Restrictive Fluid Therapy on Urethral Tissue Perfusion in Hepatobiliary Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04092608
- Acronym / sponsor ID
- B406201940521
- Conditions
- Liver Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Bicetre Hospital
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 17 Sep 2019 (actual)
- 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.
"Restrictive" fluid management is usually the current standard practice for patients undergoing liver surgery. The general idea is to maintain a low central venous pressure in order to decrease blood loss and improve the quality of the surgical field. However, this strategy , considered as rather "restrictive", can be associated with patient's harm, mainly acute kidney injury.
Today, Goal directed fluid therapy (GDFT) is a well accepted strategy to optimize fluid administration in patients undergoing major surgery which aimed to maintain normovolemia without being too liberal.
The goal of this randomized controlled trial is to compare these two strategies on Urethral Perfusion index measured with a new IKORUS UP probe (Foley catheter made smarter with embedded photoplethysmographic sensing technology).
Detailed description
Restrictive fluid administration aiming at maintaining a low central venous pressure (low-CVP) during liver surgery has always been considered as a "gold standard" strategy because it decrease blood loss and improve the quality of the surgical field. However, this strategy , rather "restrictive", can be associated with patient harm (mainly AKI).
Today, Goal directed fluid therapy (GDFT) is a well accepted strategy to optimize fluid administration in patients undergoing major surgery.Some studies have shown that this strategy is feasible for such patient population.
There is currently a lack of data supporting the advantage of one strategy over the other in this patient population.While a restrictive fluid strategy can advantage the surgeon, it can also disadvantage the patient as in order to avoid hypotension, vasopressors administration is required. If the patient is hypovolemic, such strategy may cause acute kidney injury.
The goal of this randomized controlled trial is to compare these two strategies on Urethral Perfusion index measured with a new Foley catheter with embedded photoplethysmographic sensing technology). This new technology allows for continuous and easy monitoring of urethral tissue perfusion
The investigators hypothesis is that patients in the GDFT group will have better Urethral Perfusion index (uPI) during surgery (via a better cardiac blood flow optimization) compared to patients in the restrictive (low CVP) group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single center randomized controlled superiority study
| Arm | Type | Receives |
|---|---|---|
| Low CVP group (restrictive group) | Active comparator | Procedure: LOW CVP (restrictive group)Standard practice: the goal is to keep the CVP < 7 mmHg during surgery. Baseline of crystalloid of 2ml/kg/h max in all patients. EV 1000 monitoring device (Edwards Lifesciences, Irvine, USA) will be used but values will be blinded to the anesthesiologist in charge of the patient. Mean Arterial pressure (MAP) should be kept over 65mmHg during surgery (standard practice) with continuous norepinephrine infusion Additionnal fluid administration is given to the patient at the end of the surgery (standard practice) UPi is blinded in all groups |
| GDFT group | Experimental | Procedure: GDFTThe goal is to keep stroke volume variation below 13% during surgery with mini fluid challenge of 100 ml of balanced crystalloid using the monitoring device (Edwards Lifesciences, Irvine, USA). Of course, the values will not be blinded to the anesthesiologist in charge of the patient. All patients have a baseline crystalloid: 2ml/kg/h and mini fluid challenges per 100 ml as described above. Mean Arterial pressure (MAP) should be kept over 65mmHg during surgery (standard practice) with continuous norepinephrine infusion UPi is blinded in all groups |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -All adults patients undergoing a liver surgery and equipped with a cardiac output monitoring device
Key exclusion criteria (1 listed)
- -Atrial fibrillation
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 |
|---|---|---|
| GDFTThe titration of fluid will be based on stroke volume variation. The goal is to maintain this variable < 13% during surgery with multiple mini fluid challenge of 100 ml of balanced crystalloid. | Procedure or surgery | GDFT group |
| LOW CVP (restrictive group)Goal = CVP < 7mmHg and only 2 ml/kg/h max during surgery. | Procedure or surgery | Low CVP group (restrictive group) |
Primary outcome
Urethral Perfusion index
Time frame: during surgery
average of the Urethral Perfusion index values
10 secondary outcomes
Urethral Perfusion index
Time frame: during surgery
Urethral Perfusion index
Time frame: during surgery
Amount of fluid during surgery
Time frame: during surgery
Amount of vasopressors
Time frame: during surgery
Stroke volume index
Time frame: during surgery
stroke volume variation
Time frame: during surgery
cardiac index
Time frame: during surgery
incidence of acute kidney injury
Time frame: At postoperative day 7
length of stay in the hospital
Time frame: Postoperative day 30
Incidence of postoperative complications
Time frame: Postoperative day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Derived from this study: PubMed 34669645Chirnoaga D, Coeckelenbergh S, Ickx B, Van Obbergh L, Lucidi V, Desebbe O, Carrier FM, Michard F, Vincent JL, Duranteau J, Van der Linden P, Joosten A. Impact of conventional vs. goal-directed fluid therapy on urethral tissue perfusion in patients undergoing liver surgery: A pilot randomised controlled trial. Eur J Anaesthesiol. 2022 Apr 1;39(4):324-332. doi: 10.1097/EJA.0000000000001615.
- Individual participant dataSharing planned: No
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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.
Alexandre Joosten, MD PhD principal investigator
ERASME
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GDFT and LOW CVP (restrictive group) in people with Liver Surgery, run by Erasme University Hospital at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urethral Perfusion index (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092608, which also lists 1 linked publication.
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 11 Aug 2020; AzTrials last refreshed its copy on 30 Oct 2026.