NCT06900972

Effect of Colloids Versus Crystalloids on Heart Mechanics: a Double-blind Cross Over Randomized Trial

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 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

Interventions

Type	Name	Description
DRUG	Gelafundin	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	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

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-08-30
• Completion: 2025-09-30
• First posted: 2025-03-28
• Last updated: 2025-03-28

Locations

1 site across 1 country: Tunisia