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

This study has been completed.
Sponsor:
Information provided by:
Innogene Kalbiotech Pte. Ltd
ClinicalTrials.gov Identifier:
NCT01433276
First received: August 10, 2011
Last updated: September 12, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Hemorrhagic Shock
Drug: Hyperosmolar sodium lactate
Drug: Ringer's lactate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Innogene Kalbiotech Pte. Ltd:

Primary Outcome Measures:
  • Urinary output (UOP) [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
  • Mean arterial pressure [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
  • Heart rate [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
  • Respiration rate [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
  • Glasgow coma scale value [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
  • Fluid balance [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: July 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433276

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

No publications provided

Responsible Party: Dr Rikrik Ilyas, Director, Innogene Kalbiotech Pte. Ltd.
ClinicalTrials.gov Identifier: NCT01433276     History of Changes
Other Study ID Numbers: 009/IGK-KAL/09
Study First Received: August 10, 2011
Last Updated: September 12, 2011
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Innogene Kalbiotech Pte. Ltd:
Fluid resuscitation
hemorrhagic shock
Totilac
Ringer's
trauma

Additional relevant MeSH terms:
Shock
Shock, Hemorrhagic
Pathologic Processes
Hemorrhage

ClinicalTrials.gov processed this record on April 17, 2014