Status:
COMPLETED
Efficacy, Safety of Solution Containing Hyperosmolar Sodium Lactate Infusion for Resuscitation of Patients With Hemorrhagic Shock
Lead Sponsor:
Innogene Kalbiotech Pte. Ltd
Conditions:
Hemorrhagic Shock
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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....
Detailed Description
Trauma is still an important cause of death and disability worldwide.Trauma patients often experience fluid deficits. In addition to apparent blood loss, fluid deficit might also occur secondary to ge...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01433276
Start Date
July 1 2009
End Date
January 1 2011
Last Update
September 13 2011
Active Locations (1)
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1
Department of Surgery, Dr. Hasan Sadikin Hospital
Bandung, Indonesia