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Study comparing effectiveness of two intra venous fluids or solutions in restoring the blood pressure and compensating loss of blood in injured patients in emergency.

Open labelled randomized clinical trial using Plasmalyte A vs Ringer lactate in trauma resuscitation in Emergency department in a tertiary care hospital in Bangalore

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022024
Enrollment
60
Registered
2019-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: T149- Unspecified injury

Interventions

Intervention1: plasmalyte a intra venous fluid: one liter of plasmalyte a is given intra venously to trauma patients over 15 min who need resuscitation and met inclusion criteria Control Intervention1

Sponsors

MEERA JOSE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All blunt and penetrating trauma cases with New Trauma Score Indication for at least one PRBC transfusion within 6 hours of trauma The delay between trauma and hospital arrival

Exclusion criteria

Exclusion criteria: Chronic kidney disease patients Patients who received >500 ml fluid before arrival to ER Pregnancy Patient with chronic liver disease decompensated Patient with cardiac disease â?? cardiac failure

Design outcomes

Primary

MeasureTime frame
Change in pH and base excess and changes in lactate levels at 0 and 60 minutes in Venous blood gas samplesTimepoint: At 0 minute and 60 minutes

Secondary

MeasureTime frame
Proportion of all cause mortality at day 7/ day 30 Proportion of patients requiring renal replacement therapy Amount of transfused blood product units Proportion of patients undergoing Surgery Comparison of efficiency of both fluid in correction of hemodynamic parameters Timepoint: At day 7 and day 30 Hemodynamic parameters from 0 minute to 60 minutes

Countries

India

Contacts

Public ContactDr Meera Jose

Bangalore Baptist Hospital

drjacobmv1968@gmail.com9945216226

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026