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

Phase 3

• Conditions: Fluid Therapy; Fluid Reponsiveness; Fluid Resuscitation
• Interventions: Drug: Gelafundin; Drug: Saline (NaCl 0,9 %) (placebo)

• Registration Number: NCT06900972
• Lead Sponsor: University of Monastir

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Start: 2025-04-01
• Primary Completion: 2025-08-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• HealthyVolunteers with age > 18 years without medical history

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AB	Gelafundin	Patients will blindly receive colloids then after a washout period of 7 days a cristalloids solute will be administered
AB	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	Gelafundin	Patients will blindly receive cristalloids then after a washout period of 7 days a colloids solute will be administered.
BA	Saline (NaCl 0,9 %) (placebo)	Patients will blindly receive cristalloids then after a washout period of 7 days a colloids solute will be administered.

Primary Outcome Measures

Name	Time	Method
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	1 day

Trial Locations

Locations (1)

Fattouma Bourguiba Hospital; 🇹🇳 MOnastir, Tunisia