NCT01433276

The Clinical Efficacy and Safety of a Proprietary Solution Containing Hypertonic Sodium Lactate (Totilac®) Infusion for Resuscitation of Patients With Hemorrhagic Shock Due to Multiple Injuries

Completed Phase 3 Last updated 12 September 2011

What this trial tests

Phase 3 trial testing Hyperosmolar sodium lactate in Hemorrhagic Shock in 71 participants. Completed in 1 January 2011.

Timeline

1 July 2009

Primary endpoint
1 January 2011

1 January 2011

Quick facts

Lead sponsor	Innogene Kalbiotech Pte. Ltd
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	1 July 2009
Primary completion	1 January 2011
Estimated completion	1 January 2011
Sites	1 location across Indonesia

Drugs / interventions tested

• Hyperosmolar sodium lactate — full drug profile →
• Ringer's lactate

Conditions studied

• Hemorrhagic Shock — all drugs for Hemorrhagic Shock →

Sponsor

Innogene Kalbiotech Pte. Ltd — full company profile →

Who can join

Adults 18 to 65, any sex, with Hemorrhagic Shock. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Urinary output (UOP)
  Time frame: 3 hours

Sponsor's own description

Indication: Resuscitation in pts with hemorrhagic shock due to multiple injuries

Prospective, open label RCT in pts. with traumatic hemorrhagic shock in RS Hasan Sadikin Hospital, Indonesia.

PI: Dr. Kiki Lukman, PsBD(K), Surgery, RSHS. Co-PI: (late)Prof. Xavier Leverve MD, PhD, Directeur, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université Joseph Fourier, France

Hemorrhagic shock is a cause of death in trauma.Fluid resuscitation to ensure stable hemodynamics and microcirculation by rapidly restoring circulating plasma volume could be a cornerstone of managing trauma patients. Excessive fluid accumulation particularly in the interstitial tissue should be avoided. Hypertonic solution shows promise in restoring intravascular volume expansion and microcirculation with less fluid infusion in hypovolemic patients. This study investigated efficacy and safety of hyperosmolar Na lactate(Totilac®) for resuscitating traumatic hemorrhagic shock patients.

Patients with multiple injuries with grade III hemorrhagic shock and RTS ≥4 received std initial fluid resuscitation of upto 2 liters of isotonic crystalloid. They also got similar dose of either hyperosmolar Na lactate or ringer's lactate. Hemodynamic status, fluid balance and and safety was recorded during the study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Innate immunity and immunotherapy for hemorrhagic shock.
   Huang Q, Gao S, Yao Y, Wang Y, et al · · 2022 · cited 16× · PMID 36091025 · DOI 10.3389/fimmu.2022.918380