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

U

University of Monastir

Status and phase

Invitation-only
Phase 3

Conditions

Fluid Therapy
Fluid Reponsiveness
Fluid Resuscitation

Treatments

Drug: Saline (NaCl 0,9 %) (placebo)
Drug: Gelafundin

Study type

Interventional

Funder types

Other

Identifiers

NCT06900972
TN2025-NAT-INS-125

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

16 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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