AbdominoplastyNCT05939518
Fluid Therapy and Glycocalyx Shedding During Moderate Surgery
A study testing Lactated Ringer's Fluid Bolus Response to Low Urinary Output and Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol in people with Abdominoplasty, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Goal-directed fluid therapy is one of the most accepted strategies in intraoperative fluid therapy, although potential fluid overload is a possible drawback. Fluid overload has recently been shown to cause damage to the glycocalyx and to increase extravasation of fluids into the interstitial space. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Abdominoplasty
- What is being tested?
- Lactated Ringer's Fluid Bolus Response to Low Urinary Output and Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIsrael
- Study dates
- 13 May 2020to 3 Aug 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for abdominoplasty.
- American Society of Anesthesiologists Classification 1 or 2.
Who cannot join
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Contribution of Liberal Fluid Therapy to Glycocalyx Shedding, Interstitial Edema and Fluid Accumulation During Moderate Surgery
Goal-directed fluid therapy is one of the most accepted strategies in intraoperative fluid therapy, although potential fluid overload is a possible drawback. Fluid overload has recently been shown to cause damage to the glycocalyx and to increase extravasation of fluids into the interstitial space.
This study aims to determine whether liberal fluid administration during moderate surgery results in impairment to the endothelial glycocalyx and causes edema.
Participants will be randomized to receive either a liberal or restrictive fluid protocol with vasopressor support. The investigators will measure interstitial edema by clinical signs, pulmonary congestion by ultrasound, and extracellular water by bioimpedance. Impairment of glycocalyx will be estimated by measuring blood levels of shedding markers. In addition, wound healing and early postoperative outcome will be estimated by POMS.
- Conditions
- Abdominoplasty
- Being tested
- Lactated Ringer's Fluid Bolus Response to Low Urinary Output, Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol
- Keywords
- Glycocalyx, IV Fluids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringer's Fluid Bolus Response to Low Urinary OutputOther
During the surgical procedure and the subsequent stay in the Post-Anesthesia Care Unit: if the study participant's urine output (UO) remains <0.3 ml/kg/h for two consecutive hours, an IV bolus of 250 ml of lactated Ringer's solution will be administered over 15 min and repeated every 30 min until the UO reaches >0.3 ml/kg/h.
Post-Anesthesia Care Unit Lactated Ringer's Fluid Management ProtocolOther
Also called Recovery Room Fluid Management Protocol
During their stay in the Post-Anesthesia Care Unit, patients will receive a 1.5 ml/kg/h IV infusion of lactated Ringer's solution.
| Study group | Role | What they receive |
|---|---|---|
| Liberal Lactated Ringer Fluid Protocol with Ephedrine and Phenylephrine Boluses | Experimental | IV Infusion of 500 ml of lactated Ringer's (RL) solution during the induction of anesthesia followed by an infusion of RL at a rate of 8.0 ml/kg/h throughout the maintenance phase of anesthesia. The anesthesia care provider will be allowed free use of IV boluses of ephedrine or phenylephrine to target a mean arterial blood pressure of >60 mmHg. Receives: Other: Lactated Ringer's Fluid Bolus Response to Low Urinary Output; Other: Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol |
| Restrictive Lactated Ringer Fluid Protocol with Noradrenaline Infusion | Active comparator | IV Infusion of 200 ml of lactated Ringer's (RL) solution during the induction of anesthesia followed by an infusion of RL at a rate of 2.0 ml/kg/h + an infusion of noradrenaline throughout the maintenance phase of anesthesia, through a large peripheral vein. The noradrenaline infusion rate will be titrated after an initial bolus of 10 μg, from an initial rate of 2.0 μg/kg/h, which may be raised up to 8.0 μg/kg/h, to target a mean arterial blood pressure (MBP) of >60 mmHg. If the MBP target is still not achieved, the RL infusion rate may be increased up to 4.0 ml/kg/h. Receives: Other: Lactated Ringer's Fluid Bolus Response to Low Urinary Output; Other: Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from preoperative serum concentration of Heparan Sulfate.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Measured: Two hours after completion of surgery.
Change from preoperative serum concentration of Syndecan-1.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Measured: Two hours after completion of surgery.
Change from preoperative serum concentration of Hyaluronic Acid.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Measured: Two hours after completion of surgery.
Change from preoperative serum concentration of Sphingosine-1-Phosphate.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Measured: Two hours after completion of surgery.
Appearance of B-lines on lung ultrasonography.
Bilateral ultrasonography of the study participant's lungs, performed by a physician using two views: posterior and lateral.
Measured: Two hours after completion of surgery.
Early appearance of peripheral pitting edema.
Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.
Measured: Two hours after completion of surgery.
Late appearance of peripheral pitting edema.
Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.
Measured: During the first postoperative day.
Postoperative Morbidity Survey (POMS) Score.
Clinically evaluated by a physician for each study participant.
Measured: During the first postoperative day.
Early change in the percentage of Total Body Water and Extracellular Water.
Measured by bioimpedance using a commercially available device connected to the study participant.
Measured: Immediately after completion of surgery.
Late change in the percentage of Total Body Water and Extracellular Water.
Measured by bioimpedance using a commercially available device connected to the study participant.
Measured: Two hours after completion of surgery.
Secondary outcomes (12)
Change from preoperative body weight.
Recorded while the study participant stands on an electronic scale.
Measured: During the first postoperative day.
Volume of urine produced during the procedure.
Measured using a volumetric graduated urine collection container connected to a Foley catheter placed in the urinary bladder of the study participant.
Measured: Immediately after completion of surgery.
Change from preoperative Heart Rate.
Measured using a continuous electrocardiography monitor connected to the study participant.
Measured: Immediately after completion of surgery.
Change from preoperative Mean Arterial Blood Pressure.
Measured using an automated oscillometric blood pressure monitoring device with its cuff placed on one of the arms of the study participant.
Measured: Immediately after completion of surgery.
Early change from preoperative Cardiac Output.
Measured non-invasively using a commercially available device connected to the study participant.
Measured: Immediately after completion of surgery.
Late change from preoperative Cardiac Output.
Measured non-invasively using a commercially available device connected to the study participant.
Measured: Two hours after completion of surgery.
Early change from preoperative serum concentration of C-Reactive Protein.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Measured: Immediately after completion of surgery.
Late change from preoperative serum concentration of C-Reactive Protein.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Measured: Two hours after completion of surgery.
Early change from preoperative serum concentration of Lactate.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Measured: Immediately after completion of surgery.
Late change from preoperative serum concentration of Lactate.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Measured: Two hours after completion of surgery.
Change from preoperative serum concentration of Creatinine.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Measured: Immediately after completion of surgery.
Change from preoperative serum concentration of Hemoglobin.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Measured: Immediately after completion of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start13 May 2020
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Sponsor
- Investigators
- Galel Yakobi, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939518
- Sponsor's protocol ID
- 0388-19-HMO
- Other IDs
- 008932_2020-05-12_MOH
- Status last verified
- Dec 2024
- First submitted
- 15 Jun 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Liberal Fluid Therapy to Glycocalyx Shedding, Interstitial Edema and Fluid Accumulation During Moderate Surgery
- ClinicalTrials.gov ID
- NCT05939518
- Acronym / sponsor ID
- 0388-19-HMO
- Conditions
- Abdominoplasty
- Keywords
- Glycocalyx, IV Fluids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- 13 May 2020 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 11 Jul 2023 (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.
Goal-directed fluid therapy is one of the most accepted strategies in intraoperative fluid therapy, although potential fluid overload is a possible drawback. Fluid overload has recently been shown to cause damage to the glycocalyx and to increase extravasation of fluids into the interstitial space.
This study aims to determine whether liberal fluid administration during moderate surgery results in impairment to the endothelial glycocalyx and causes edema.
Participants will be randomized to receive either a liberal or restrictive fluid protocol with vasopressor support. The investigators will measure interstitial edema by clinical signs, pulmonary congestion by ultrasound, and extracellular water by bioimpedance. Impairment of glycocalyx will be estimated by measuring blood levels of shedding markers. In addition, wound healing and early postoperative outcome will be estimated by POMS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal Lactated Ringer Fluid Protocol with Ephedrine and Phenylephrine Boluses | Experimental | Other: Lactated Ringer's Fluid Bolus Response to Low Urinary Output, Other: Post-Anesthesia Care Unit Lactated Ringer's Fluid Management ProtocolIV Infusion of 500 ml of lactated Ringer's (RL) solution during the induction of anesthesia followed by an infusion of RL at a rate of 8.0 ml/kg/h throughout the maintenance phase of anesthesia. The anesthesia care provider will be allowed free use of IV boluses of ephedrine or phenylephrine to target a mean arterial blood pressure of >60 mmHg. |
| Restrictive Lactated Ringer Fluid Protocol with Noradrenaline Infusion | Active comparator | Other: Lactated Ringer's Fluid Bolus Response to Low Urinary Output, Other: Post-Anesthesia Care Unit Lactated Ringer's Fluid Management ProtocolIV Infusion of 200 ml of lactated Ringer's (RL) solution during the induction of anesthesia followed by an infusion of RL at a rate of 2.0 ml/kg/h + an infusion of noradrenaline throughout the maintenance phase of anesthesia, through a large peripheral vein. The noradrenaline infusion rate will be titrated after an initial bolus of 10 μg, from an initial rate of 2.0 μg/kg/h, which may be raised up to 8.0 μg/kg/h, to target a mean arterial blood pressure (MBP) of >60 mmHg. If the MBP target is still not achieved, the RL infusion rate may be increased up to 4.0 ml/kg/h. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for abdominoplasty.
- American Society of Anesthesiologists Classification 1 or 2.
Key exclusion criteria (1 listed)
- Pregnancy.
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 |
|---|---|---|
| Lactated Ringer's Fluid Bolus Response to Low Urinary OutputDuring the surgical procedure and the subsequent stay in the Post-Anesthesia Care Unit: if the study participant's urine output (UO) remains <0.3 ml/kg/h for two consecutive hours, an IV bolus of 250 ml of lactated Ringer's solution will be administered over 15 min and repeated every 30 min until the UO reaches >0.3 ml/kg/h. | Other | Liberal Lactated Ringer Fluid Protocol with Ephedrine and Phenylephrine Boluses, Restrictive Lactated Ringer Fluid Protocol with Noradrenaline Infusion |
| Post-Anesthesia Care Unit Lactated Ringer's Fluid Management ProtocolAlso: Recovery Room Fluid Management ProtocolDuring their stay in the Post-Anesthesia Care Unit, patients will receive a 1.5 ml/kg/h IV infusion of lactated Ringer's solution. | Other | Liberal Lactated Ringer Fluid Protocol with Ephedrine and Phenylephrine Boluses, Restrictive Lactated Ringer Fluid Protocol with Noradrenaline Infusion |
Primary outcome
Change from preoperative serum concentration of Heparan Sulfate.
Time frame: Two hours after completion of surgery.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Change from preoperative serum concentration of Syndecan-1.
Time frame: Two hours after completion of surgery.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Change from preoperative serum concentration of Hyaluronic Acid.
Time frame: Two hours after completion of surgery.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Change from preoperative serum concentration of Sphingosine-1-Phosphate.
Time frame: Two hours after completion of surgery.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Appearance of B-lines on lung ultrasonography.
Time frame: Two hours after completion of surgery.
Bilateral ultrasonography of the study participant's lungs, performed by a physician using two views: posterior and lateral.
Early appearance of peripheral pitting edema.
Time frame: Two hours after completion of surgery.
Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.
Late appearance of peripheral pitting edema.
Time frame: During the first postoperative day.
Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.
Postoperative Morbidity Survey (POMS) Score.
Time frame: During the first postoperative day.
Clinically evaluated by a physician for each study participant.
Early change in the percentage of Total Body Water and Extracellular Water.
Time frame: Immediately after completion of surgery.
Measured by bioimpedance using a commercially available device connected to the study participant.
Late change in the percentage of Total Body Water and Extracellular Water.
Time frame: Two hours after completion of surgery.
Measured by bioimpedance using a commercially available device connected to the study participant.
12 secondary outcomes
Change from preoperative body weight.
Time frame: During the first postoperative day.
Volume of urine produced during the procedure.
Time frame: Immediately after completion of surgery.
Change from preoperative Heart Rate.
Time frame: Immediately after completion of surgery.
Change from preoperative Mean Arterial Blood Pressure.
Time frame: Immediately after completion of surgery.
Early change from preoperative Cardiac Output.
Time frame: Immediately after completion of surgery.
Late change from preoperative Cardiac Output.
Time frame: Two hours after completion of surgery.
Early change from preoperative serum concentration of C-Reactive Protein.
Time frame: Immediately after completion of surgery.
Late change from preoperative serum concentration of C-Reactive Protein.
Time frame: Two hours after completion of surgery.
Early change from preoperative serum concentration of Lactate.
Time frame: Immediately after completion of surgery.
Late change from preoperative serum concentration of Lactate.
Time frame: Two hours after completion of surgery.
Change from preoperative serum concentration of Creatinine.
Time frame: Immediately after completion of surgery.
Change from preoperative serum concentration of Hemoglobin.
Time frame: Immediately after completion of surgery.
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 18 Dec 2024.
Related trials for Abdominoplasty
Not yet recruitingObservational study
Gastroesophageal Reflux and Respiratory Function in Patients Undergoing Abdominoplasty
Abdominoplasty, Diaphragm
Enrolling by invitation
Patient Satisfaction and Reflection on Drain Placement
Abdominoplasty, Panniculectomy
RecruitingObservational study
Comparison of the Efficacy of Transversus Abdominis Plane Block and Erector Spinae Plane Block in Postoperative Analgesia Management After Abdominoplasty
Abdominoplasty, Postoperative Pain
Active, not recruiting
Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery
Quadratus Lumborum Block, Abdominoplasty
Recruiting
Combined Ultrasound Guided Bilateral Rectus Sheath and Erector Spinae Plain Blocks Versus Erector Spinae Plain Block for Intra and Postoperative Analgesia in Elective Abdominoplastic Surgeries. a Randomized Controlled Double Blinded Trial.
Abdominoplasty, Perioperative Analgesia
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.
Galel Yakobi, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactated Ringer's Fluid Bolus Response to Low Urinary Output and Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol in people with Abdominoplasty, run by Hadassah Medical Organization at 1 site in Israel.
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 2 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 18 Dec 2024. 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 Israel. 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?
Change from preoperative serum concentration of Heparan Sulfate. (time frame: Two hours after completion of surgery.). The study lists 10 primary outcomes in all. 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 18 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.