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

NCT06900972 | Enrolling By Invitation Phase 3

• 1 other identifier: TN2025-NAT-INS-125
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Reponsiveness; Fluid Resuscitation; Fluid Therapy

Keywords

colloids; cristalloids; heart mechanics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

AB

OTHER

Patients will blindly receive colloids then after a washout period of 7 days a cristalloids solute will be administered

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.

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

Interventions

Gelafundin 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.

AB; BA

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

AB; BA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HealthyVolunteers with age \> 18 years without medical history

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Fattouma Bourguiba Hospital

Monastir, Tunisia, 5000, Tunisia

Location

Related Publications (1)

• Myburgh JA, Mythen MG. Resuscitation fluids. N Engl J Med. 2013 Sep 26;369(13):1243-51. doi: 10.1056/NEJMra1208627. No abstract available.

  PMID: 24066745 BACKGROUND

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Nidhal Bouchahda

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: April 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

TU (1)