Fluid Electrolyte DisordersNCT06474052
Volume Kinetics of Gelofusine 4% During Vascular Surgery
An observational study of Fluid Electrolyte Disorders, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 1 site in Romania.
Trial summary
The volume kinetics of the commercially available colloid fluid, Gelofusine 4%, have not been previously studied. Adult patients undergoing open vascular surgery, including femoral and carotid endarterectomy as well as bypass surgery, received general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Electrolyte Disorders
- What is being tested?
- Gelofusine 4%
- How many people
- 15 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2024to 15 Apr 2024
- Phase
- Observational
- 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
Study population: Adult patients aged 18 to 80 years undergoing uncomplicated vascular surgery under general anesthesia.
Who may be able to join
- Informed consent.
- Elective open vascular surgery with a minimal risk of perioperative complications.
- Hemodynamic stability before induction (no chest pain, SBP > 100 mmHg, MAP ≥ 60 mmHg, 50 < HR < 100 bpm).
Who cannot join
- Known allergy to 4% Gelofusine.
- Patient refusal to participate in the study.
- Non-elective/emergency surgical interventions.
- The American Society of Anesthesiologists (ASA) > 3.
- Any preoperative hemodynamic support (mechanical or pharmacological).
- Moderate or severe left ventricular dysfunction (LVEF ≤ 44%).
Show all 9Show fewer
- Moderate or severe right ventricular dysfunction.
- Diastolic dysfunction of any degree.
- Baseline hypoxemia index < 300 mmHg.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Institutul de Urgenta de Boli Cardiovasculare Prof Dr CC Iliescu
Bucharest, Bucharest, 022328
About this study
Official title: Volume Kinetics of Gelofusine 4% During Uncomplicated Vascular Surgery
The volume kinetics of the commercially available colloid fluid, Gelofusine 4%, have not been previously studied. Adult patients undergoing open vascular surgery, including femoral and carotid endarterectomy as well as bypass surgery, received general anesthesia. Following the induction of anesthesia, Gelofusine 4% was administered at a dosage of 10 ml/kg over a 30-minute period. Hemoglobin concentration was monitored for up to 180 minutes post-administration to construct a plasma hemodilution profile.
Read the detailed description
Gelofusine 4% was administered at a dosage of 10 ml/kg over a 30-minute period to adult patients undergoing uncomplicated vascular surgery. Arterial blood samples were taken to measure blood hemoglobin concentration and hematocrit at baseline and at 5-minute intervals up to 60 minutes after the infusion began, followed by 10-minute intervals up to 90 minutes, and then at 30-minute intervals up to 180 minutes. Urine output and total intraoperative blood loss were continuously monitored. The plasma hemodilution data were fitted to a bicompartmental model to derive the intercompartmental kinetics of Gelofusine 4%.
- Conditions
- Fluid Electrolyte Disorders
- Being tested
- Gelofusine 4%
- Keywords
- colloid, volume kinetics, Gelofusine 4%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelofusine 4%Drug
Also called Colloid
Gelofusine 4% 10 ml/kg is administered following anaesthesia induction in 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Gelofusine 4% | Adult patients undergoing uncomplicated vascular surgery. Receives: Drug: Gelofusine 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Volume
Plasma volume was determined using a two-compartment kinetic model with three rate constants (k12, k21, and k10) and a scaling factor (Vc, central volume) that relates dilution to volume. This model was applied to the dependent variables, which included frequently measured plasma dilution and urinary excretion.
Measured: 180 minutes after the start of the Gelofusine 4% infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jan 2024
- Primary completion31 Mar 2024
- Study completion15 Apr 2024
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 Fluid Electrolyte DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balan Ion Cosmin, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Investigators
- Robert Hahn, Professor, Study director, Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474052
- Sponsor's protocol ID
- 1391
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Balan C, Boros C, Bubenek-Turconi SI, Hahn RG. Volume Kinetics of Gelofusine 4% During Vascular Surgery. Clin Pharmacokinet. 2025 Apr;64(4):599-610. doi: 10.1007/s40262-025-01500-9. Epub 2025 Mar 23.
PubMed 40121598
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Kinetics of Gelofusine 4% During Uncomplicated Vascular Surgery
- ClinicalTrials.gov ID
- NCT06474052
- Acronym / sponsor ID
- 1391
- Conditions
- Fluid Electrolyte Disorders
- Keywords
- colloid, volume kinetics, Gelofusine 4%
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. IliescuUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 25 Jun 2024 (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.
The volume kinetics of the commercially available colloid fluid, Gelofusine 4%, have not been previously studied. Adult patients undergoing open vascular surgery, including femoral and carotid endarterectomy as well as bypass surgery, received general anesthesia. Following the induction of anesthesia, Gelofusine 4% was administered at a dosage of 10 ml/kg over a 30-minute period. Hemoglobin concentration was monitored for up to 180 minutes post-administration to construct a plasma hemodilution profile.
Detailed description
Gelofusine 4% was administered at a dosage of 10 ml/kg over a 30-minute period to adult patients undergoing uncomplicated vascular surgery. Arterial blood samples were taken to measure blood hemoglobin concentration and hematocrit at baseline and at 5-minute intervals up to 60 minutes after the infusion began, followed by 10-minute intervals up to 90 minutes, and then at 30-minute intervals up to 180 minutes. Urine output and total intraoperative blood loss were continuously monitored. The plasma hemodilution data were fitted to a bicompartmental model to derive the intercompartmental kinetics of Gelofusine 4%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gelofusine 4% | – | Drug: Gelofusine 4%Adult patients undergoing uncomplicated vascular surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 to 80 years undergoing uncomplicated vascular surgery under general anesthesia.
Key inclusion criteria (3 listed)
- Informed consent.
- Elective open vascular surgery with a minimal risk of perioperative complications.
- Hemodynamic stability before induction (no chest pain, SBP > 100 mmHg, MAP ≥ 60 mmHg, 50 < HR < 100 bpm).
Key exclusion criteria (9 listed)
- Known allergy to 4% Gelofusine.
- Patient refusal to participate in the study.
- Non-elective/emergency surgical interventions.
- The American Society of Anesthesiologists (ASA) > 3.
- Any preoperative hemodynamic support (mechanical or pharmacological).
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 |
|---|---|---|
| Gelofusine 4%Also: ColloidGelofusine 4% 10 ml/kg is administered following anaesthesia induction in 30 minutes. | Drug | Gelofusine 4% |
Primary outcome
Plasma Volume
Time frame: 180 minutes after the start of the Gelofusine 4% infusion
Plasma volume was determined using a two-compartment kinetic model with three rate constants (k12, k21, and k10) and a scaling factor (Vc, central volume) that relates dilution to volume. This model was applied to the dependent variables, which included frequently measured plasma dilution and urinary excretion.
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 25 Jun 2024.
- Derived from this study: PubMed 40121598Balan C, Boros C, Bubenek-Turconi SI, Hahn RG. Volume Kinetics of Gelofusine 4% During Vascular Surgery. Clin Pharmacokinet. 2025 Apr;64(4):599-610. doi: 10.1007/s40262-025-01500-9. Epub 2025 Mar 23.
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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.
Robert Hahn, Professor study director
Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Electrolyte Disorders, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 1 site in Romania.
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 3 inclusion and 9 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 25 Jun 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 Romania. 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?
Plasma Volume (time frame: 180 minutes after the start of the Gelofusine 4% infusion). 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 NCT06474052, 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 25 Jun 2024.