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

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

August 30, 2025

Study Completion Date

September 30, 2025

Conditions
Fluid ReponsivenessFluid ResuscitationFluid Therapy
Interventions
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

Trial Locations (1)

5000

Fattouma Bourguiba Hospital, Monastir

All Listed Sponsors
lead

University of Monastir

OTHER