Fluid ReponsivenessPhase 3NCT06900972
Effect of Colloids Versus Crystalloids on Heart Mechanics: a Double-blind Cross Over Randomized Trial
A Phase 3 study testing Gelafundin in people with Fluid Reponsiveness and Fluid Resuscitation, run by University of Monastir at 1 site in Tunisia.
Trial summary
The debate over whether to use colloid or crystalloid solutions for fluid resuscitationis still ongoing. Colloid solutions consist of large molecules that generally cannot pass through healthy capillary membranes, whereas crystalloid solutions contain ions that easily move from the intravascular space to the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluid Reponsiveness, Fluid Resuscitation, Fluid Therapy
- What is being tested?
- Gelafundin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Apr 2025to 30 Sep 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HealthyVolunteers with age > 18 years without medical history
Who cannot join
- History of cardio vascular diseases Diabetes Hypertension Currentpregnancy Knownallergy to one of the tested products Leftventricular dysfunction discovered at baseline assessment Valvular heart or other structural diseases discovered at base line assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The debate over whether to use colloid or crystalloid solutions for fluid resuscitationis still ongoing. Colloid solutions consist of large molecules that generally cannot pass through healthy capillary membranes, whereas crystalloid solutions contain ions that easily move from the intravascular space to the interstitial compartment. Therefore, it is traditionally argued that colloids are more effective at expanding intravascular volume, with a suggested ratio of 1:3 compared to crystalloids. However, there is currently limited evidence to suggest that resuscitation with one type of fluid is more effective or safer than t he other. Despite these theoretically advantageousphysiological properties, colloids have not demonstrated a clear hemodynamic benefit over crystalloids. We hypothesized that these unexpected discrepancies may be attributed to different mechanical heart responses.
- Conditions
- Fluid Reponsiveness, Fluid Resuscitation, Fluid Therapy
- Being tested
- Gelafundin, Saline (NaCl 0,9 %) (placebo)
- Keywords
- colloids, cristalloids, heart mechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelafundinDrug
Volunteers will undergo a comprehensive transthoracic echocardiography to measure left ventricular torsion, global longitudinal strain, left atrial strain and free wall right ventricular strain before any intervention. Initially, 500 ml of the specified but blinded solution will be administered, followed by a repeat of the echocardiographic process. Subsequently, an additional 500 ml will be given, totaling 1000 ml, and strain curves will be reacquired. After a washout period of 7 days, the same procedure will be repeated with the second solution.
Saline (NaCl 0,9 %) (placebo)Drug
Volunteers will undergo a comprehensive transthoracic echocardiography to measure left ventricular torsion, global longitudinal strain, left atrial strain and free wall right ventricular strain before any intervention. Initially, 500 ml of the specified but blinded solution will be administered, followed by a repeat of the echocardiographic process. Subsequently, an additional 500 ml will be given, totaling 1000 ml, and strain curves will be reacquired. After a washout period of 7 days, the same procedure will be repeated with the second solution
| Study group | Role | What they receive |
|---|---|---|
| AB | Other | Patients will blindly receive colloids then after a washout period of 7 days a cristalloids solute will be administered Receives: Drug: Gelafundin; Drug: Saline (NaCl 0,9 %) (placebo) |
| BA | Other | Patients will blindly receive cristalloids then after a washout period of 7 days a colloids solute will be administered. Receives: Drug: Gelafundin; Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart mechanics response will be assessed by using left ventricular longitudinal strain, left ventricular torsion strain curves, left atrial strain curves and right ventricular free wall strain curves
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
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 ReponsivenessStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nidhal Bouchahda, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900972
- Sponsor's protocol ID
- TN2025-NAT-INS-125
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Myburgh JA, Mythen MG. Resuscitation fluids. N Engl J Med. 2013 Sep 26;369(13):1243-51. doi: 10.1056/NEJMra1208627. No abstract available.
PubMed 24066745
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colloids Versus Crystalloids on Heart Mechanics: a Double-blind Cross Over Randomized Trial
- ClinicalTrials.gov ID
- NCT06900972
- Acronym / sponsor ID
- TN2025-NAT-INS-125
- Conditions
- Fluid Reponsiveness, Fluid Resuscitation, Fluid Therapy
- Keywords
- colloids, cristalloids, heart mechanics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 28 Mar 2025 (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 debate over whether to use colloid or crystalloid solutions for fluid resuscitationis still ongoing. Colloid solutions consist of large molecules that generally cannot pass through healthy capillary membranes, whereas crystalloid solutions contain ions that easily move from the intravascular space to the interstitial compartment. Therefore, it is traditionally argued that colloids are more effective at expanding intravascular volume, with a suggested ratio of 1:3 compared to crystalloids. However, there is currently limited evidence to suggest that resuscitation with one type of fluid is more effective or safer than t he other. Despite these theoretically advantageousphysiological properties, colloids have not demonstrated a clear hemodynamic benefit over crystalloids. We hypothesized that these unexpected discrepancies may be attributed to different mechanical heart responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB | Other | Drug: Gelafundin, Drug: Saline (NaCl 0,9 %) (placebo)Patients will blindly receive colloids then after a washout period of 7 days a cristalloids solute will be administered |
| BA | Other | Drug: Gelafundin, Drug: Saline (NaCl 0,9 %) (placebo)Patients will blindly receive cristalloids then after a washout period of 7 days a colloids solute will be administered. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- HealthyVolunteers with age > 18 years without medical history
Key exclusion criteria (1 listed)
- History of cardio vascular diseases Diabetes Hypertension Currentpregnancy Knownallergy to one of the tested products Leftventricular dysfunction discovered at baseline assessment Valvular heart or other structural diseases discovered at base line assessment
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 |
|---|---|---|
| GelafundinVolunteers will undergo a comprehensive transthoracic echocardiography to measure left ventricular torsion, global longitudinal strain, left atrial strain and free wall right ventricular strain before any intervention. Initially, 500 ml of the specified but blinded solution will be administered, followed by a repeat of the echocardiographic process. Subsequently, an additional 500 ml will be given, totaling 1000 ml, and strain curves will be reacquired. After a washout period of 7 days, the same procedure will be repeated with the second solution. | Drug | AB, BA |
| Saline (NaCl 0,9 %) (placebo)Volunteers will undergo a comprehensive transthoracic echocardiography to measure left ventricular torsion, global longitudinal strain, left atrial strain and free wall right ventricular strain before any intervention. Initially, 500 ml of the specified but blinded solution will be administered, followed by a repeat of the echocardiographic process. Subsequently, an additional 500 ml will be given, totaling 1000 ml, and strain curves will be reacquired. After a washout period of 7 days, the same procedure will be repeated with the second solution | Drug | AB, BA |
Primary outcome
Heart mechanics response will be assessed by using left ventricular longitudinal strain, left ventricular torsion strain curves, left atrial strain curves and right ventricular free wall strain curves
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 24066745Myburgh JA, Mythen MG. Resuscitation fluids. N Engl J Med. 2013 Sep 26;369(13):1243-51. doi: 10.1056/NEJMra1208627. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gelafundin in people with Fluid Reponsiveness and Fluid Resuscitation, run by University of Monastir at 1 site in Tunisia.
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: enrolling by invitation, as of the sponsor's last update on 28 Mar 2025. 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 Tunisia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Heart mechanics response will be assessed by using left ventricular longitudinal strain, left ventricular torsion strain curves, left atrial strain curves and right ventricular free wall strain curves (time frame: 1 day). 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 NCT06900972, 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 28 Mar 2025.