Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

November 30, 2024

Primary Completion Date

March 30, 2026

Study Completion Date

August 30, 2026

Conditions
Perioperative Volume ReplacementHydroxyethyl Starch
Interventions
DRUG

Hydroxyethyl starch 130/0.4

Individualized goal-directed administration of 6% Hydroxyethyl starch (HES) 130/0.4: After the induction of anesthesia, 200 ml trial fluid will be infused over 20 min. If stroke volume (SV) increases \>10%, another 200 ml fluid will be given. After that, the use of trial fluid will be determined by the patients' Stroke Volume Variation (SVV). If the SVV exceeds 12%, 200 ml trial fluid will be given over 20 min; this will be repeated until SVV \<12%. If the use of HES exceeds 30 ml/kg, sodium acetate Ringer will be replaced. In addition, patients will have a background infusion of sodium acetate Ringer's solution at 4 ml/kg/h to satisfy the maintenance fluid requirements during surgery.

DRUG

Sodium acetate Ringer

"Individualized goal-directed administration of crystalloid alone: After the induction of anesthesia, 200 ml trial fluid will be infused over 20 min.~If stroke volume (SV) increases \>10%, another 200 ml fluid will be given. After that, the use of trial fluid will be determined by the patients' Stroke Volume Variation (SVV). If the SVV exceeds 12%, 200 ml trial fluid will be given over 20 min; this will be repeated until SVV \<12%. In addition, patients will have a background infusion of sodium acetate, the maintenance fluid requirement during surgery."

Trial Locations (6)

410008

Xiangya Hospital of Central South University, Changsha

Unknown

The First Affiliated Hospital of Zhengzhou University;, Zhengzhou

The First Hospital of China Medical University, Shenyang

Shandong Provincial Qianfoshan Hospital, Jinan

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

Chaoyang Hospital of Capital Medical University, Beijing

All Listed Sponsors
lead

Xiangya Hospital of Central South University

OTHER

NCT06663254 - Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery | Biotech Hunter | Biotech Hunter