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

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 Overview

• Status: Enrolling by invitation
• Conditions: Fluid Therapy; Fluid Resuscitation; Fluid Reponsiveness
• Intervention / Treatment: Drug: Gelafundin; Drug: Saline (NaCl 0,9 %) (placebo)

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 3

Contacts and Locations

Study Locations

• Tunisia
  • MOnastir, Tunisia, 5000
    • Fattouma Bourguiba Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AB; Patients will blindly receive colloids then after a washout period of 7 days a cristalloids solute will be administered	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
Other: BA; Patients will blindly receive cristalloids then after a washout period of 7 days a colloids solute will be administered.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Monastir

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: colloids; cristalloids; heart mechanics
• Other Study ID Numbers: TN2025-NAT-INS-125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No