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COMPARISON OF TWO FLUIDS IN PATIENTS UNDERGOING SURGERY FOR BRAIN BLEEDING

COMPARISON OF 0.9% SALINE AND BALANCED SALT SOLUTION ON ACID BASE BALANCE IN PATIENTS UNDERGOING INTRACRANIAL ANEURYSM CLIPPING: A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/028078
Enrollment
50
Registered
2020-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: I608- Other nontraumatic subarachnoid hemorrhage

Interventions

Intervention1: BALANCED SALT SOLUTION: PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intrave
502 mg of Sodium Gluconate (C6H11NaO7)
368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO2•3H2O)
37 mg of Potassium Chloride, USP (KCl)
and 30 mg of Magnesium Chloride, USP (MgCl2•6H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0). PLASMA-LYTE A Injection pH 7.4 (Multiple

Sponsors

POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1) 18 – 75 years of age (2) Patients scheduled for craniotomy and clipping for ruptured intracranial aneurysm. (3) American society of anaesthesiologist (ASA)-IE and IIE patients (4) WFNS grade 1 & 2

Exclusion criteria

Exclusion criteria: 1) Pre-operative hypernatremia / hyponatremia (serum Na >150mEq/L or 2) Preoperative serum osmolality >320mosm/kg 3) WFNS grade >2 11 4) History of ventriculoperitoneal shunt 5) History of congestive heart failure, chronic obstructive airway disease or pre-existing renal disease (serum creatinine > 2mg/dl)

Design outcomes

Primary

MeasureTime frame
Effect on Acid base balance – pH, HCO3, Base deficitTimepoint: pH, HCO3, Base deficit- preoperative period, hourly intraoperative period, 24 and 48 hours postoperative period—

Secondary

MeasureTime frame
Serum lactate, anion gap Serum electrolytes (Na, K, Cl, Ca) Serum osmolality Renal Function Test: Blood Urea, Serum Creatinine Biomarkers of Acute Kidney injury: Urine Neutrophil Gelatinase Associated Lipocalin (NGAL), plasma Cystatin C Intraoperative Brain condition Neurological status at discharge by modified Rankin Scale (mRS) Long term neurological outcome at 1 and 3 months by mRSTimepoint: preop, intraop, upto 48 hours postop. Long term neurological outcome at 1 and 3 months by mRS—

Countries

India

Contacts

Public ContactSENTHIL KUMARAN S

PGIMER, CHANDIGARH

nidhibp@gmail.com7087009525

Outcome results

None listed

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