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Clinical Trials/CTRI/2020/10/028620
CTRI/2020/10/028620Not yet recruitingPhase 3

COMPARISON OF NORMAL SALINE AND BALANCED CRYSTALLOID SOLUTION ON ACID BASE AND ELECTROLYTE STATUS IN EMERGENCY NEUROSURGICAL TRAUMA PATIENTS - A PROSPECTIVE RANDOMISED DOUBLE BLIND STUDY

Trauma Centre Banaras Hindu University1 site in 1 country100 target enrollmentStarted: November 19, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Acid base and electrolyte status
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a prospective randomized double-blind study were patient population will be divided in two groups and we will be comparing normal saline and balanced crystalloid solutions..

We will look after the effects of above mentioned fluids on acid base and serum electrolyte status..

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Age group between 18 and 60 years.
  • •2.Traumatic neurosurgical emergency patients posted for decompressive craniotomy.
  • •3.Patients received from emergency of trauma centre with in 24hrs of injury after resuscitation.

Exclusion Criteria

  • •Patient/relative refusal.
  • •Patient baseline electrolytes are outside normal range.
  • •Patient on inotropic support.
  • •Patient with any systemic illness like Diabetes,Hypertension.
  • •Patient with end stage organ damage e.g. hepatic,renal or cardiovascular disorder.
  • •Patient with polytrauma.

Outcomes

Primary Outcomes

Acid base and electrolyte status

Time Frame: Preoperative, at end of surgery before extubation and 6 hr. postoperatively

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Trauma Centre Banaras Hindu University
Sponsor Class
Government medical college

Study Sites (1)

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