Efficacy, Safety of Solution Containing Hyperosmolar Sodium Lactate Infusion for Resuscitation of Patients With Hemorrhagic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433276
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : September 13, 2011
Information provided by:
Innogene Kalbiotech Pte. Ltd

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hemorrhagic Shock Drug: Hyperosmolar sodium lactate Drug: Ringer's lactate Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Totilac Drug: Hyperosmolar sodium lactate
1st loading : Upto 2 liters of Ringer's lactate, followed by Totilac which was given 5 mL/kgBW/15 minutes, followed by maintenance 2 mL/kgBW/hour for 3 hours
Other Name: Kalsolac
Active Comparator: Ringer's lactate Drug: Ringer's lactate
1st loading : Upto 2 litres of Ringer's lactate, followed by 5 mL/kgBW/15 minutes,followed by maintenance : 2 mL/kgBW/hour for 3 hours
Other Name: Lactated Ringer's solution

Primary Outcome Measures :
  1. Urinary output (UOP) [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 3 hours ]
  2. Mean arterial pressure [ Time Frame: 3 hours ]
  3. Heart rate [ Time Frame: 3 hours ]
  4. Respiration rate [ Time Frame: 3 hours ]
  5. Glasgow coma scale value [ Time Frame: 3 hours ]
  6. Fluid balance [ Time Frame: 3 hours ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, aged 18-65 years
  • Patients with grade III hemorrhagic shock (who fulfilled at least 2 of these following criteria: 1.5-2 L blood loss estimation, MAP <65 mmHg, pulse pressure <20 mmHg, heart rate >120 times/min, respiratory rate 30-40 times/min or urinary output 5-15 ml/hour) due to multiple injuries (simultaneously injuries in two or more organs of the body)
  • Survival probability is >50%, predicted by Revised Trauma Score ≥ 4 (scale 0-7.8408)
  • Given written informed consent

Exclusion Criteria:

  • Patients with burns >20% of body surface area
  • Patients with Glasgow Coma Score ≤ 13 (moderate and severe head injury)
  • Patients with systemic diseases which were already present before having trauma, such as: cancer, chronic renal failure, liver failure, decompensated heart failure, AIDS (CD4<200/uL) or HIV serology positive with HAAR
  • Hemorrhagic shock patients with trias sign: coagulopathy, acidosis and hypothermia that needs blood transfusion immediately
  • Patients who were pregnant before having trauma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01433276

Department of Surgery, Dr. Hasan Sadikin Hospital
Bandung, Indonesia
Sponsors and Collaborators
Innogene Kalbiotech Pte. Ltd
Principal Investigator: Kiki Lukman, SpBD(K) Department of Surgery, Dr. Hasan Sadikin Hospital, Bandung, Indonesia

Responsible Party: Dr Rikrik Ilyas, Director, Innogene Kalbiotech Pte. Ltd. Identifier: NCT01433276     History of Changes
Other Study ID Numbers: 009/IGK-KAL/09
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: August 2011

Keywords provided by Innogene Kalbiotech Pte. Ltd:
Fluid resuscitation
hemorrhagic shock

Additional relevant MeSH terms:
Shock, Hemorrhagic
Pathologic Processes
Pharmaceutical Solutions