NCT01433276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
Last Updated

September 13, 2011

Status Verified

August 1, 2011

Enrollment Period

1.5 years

First QC Date

August 10, 2011

Last Update Submit

September 12, 2011

Conditions

Hemorrhagic Shock

Keywords

Fluid resuscitationhemorrhagic shockTotilacRinger'strauma

Outcome Measures

Primary Outcomes (1)

  • Urinary output (UOP)

    3 hours

Secondary Outcomes (6)

  • Blood pressure

    3 hours

  • Mean arterial pressure

    3 hours

  • Heart rate

    3 hours

  • Respiration rate

    3 hours

  • Glasgow coma scale value

    3 hours

  • +1 more secondary outcomes

Study Arms (2)

Totilac

EXPERIMENTAL
Drug: Hyperosmolar sodium lactate

Ringer's lactate

ACTIVE COMPARATOR
Drug: Ringer's lactate

Interventions

Hyperosmolar sodium lactateDRUG

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

Also known as: Kalsolac
Totilac
Ringer's lactateDRUG

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

Also known as: Lactated Ringer's solution
Ringer's lactate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Dr. Hasan Sadikin Hospital

Bandung, Indonesia

Location

MeSH Terms

Conditions

Shock, HemorrhagicWounds and Injuries

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Kiki Lukman, SpBD(K)

    Department of Surgery, Dr. Hasan Sadikin Hospital, Bandung, Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 10, 2011

First Posted

September 13, 2011

Study Start

July 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

September 13, 2011

Record last verified: 2011-08

Locations

ID(1)