Hemorrhagic Shock Clinical Trial
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
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Department of Surgery, Dr. Hasan Sadikin Hospital | Bandung |
Lead Sponsor | Collaborator |
---|---|
Innogene Kalbiotech Pte. Ltd |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary output (UOP) | 3 hours | Yes | |
Secondary | Blood pressure | 3 hours | Yes | |
Secondary | Mean arterial pressure | 3 hours | Yes | |
Secondary | Heart rate | 3 hours | Yes | |
Secondary | Respiration rate | 3 hours | Yes | |
Secondary | Glasgow coma scale value | 3 hours | Yes | |
Secondary | Fluid balance | 3 hours | Yes |
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