Comparision of fluids used during surgery of head injury patients

Comparison of the efficacy of normal saline with plasmalyte in maintaining the metabolic profile in head injury patients undergoing evacuation of acute subdural hematoma- A prospective randomized trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/08/020655

Enrollment

Registered

2019-08-09

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Health Condition 1: S065- Traumatic subdural hemorrhage

Interventions

Intervention1: Plasmalyte: central venous pressure guided administration of plasmalyte as maintainence fluid Control Intervention1: normal saline: central venous pressure guided administration of norm

Eligibility

Inclusion criteria

Inclusion criteria: Patients with head injury with acute SDH posted for evacuation of acute subdural hematoma.

Exclusion criteria

Exclusion criteria: 1.Patients who suffered polytrauma with major thoracic, abdominal injuries or long bone fractures 2.Patients with pre-existing renal failure (serum creatinine > 2) or dyselectrolytemia 3.Hepatic failure 4.Preexisting coagulopathy with altered coagulation status 5.Pregnancy

Design outcomes

Primary

Measure	Time frame
Metabolic profile assessed by arterial blood gasTimepoint: Metabolic profile assessed preoperatively,every 2 hours intraoperatively and then postoperatively.	—

Secondary

Measure	Time frame
Brain relaxation score, renal parameters and coagulation profile, urinary TIMP2-IGFBP7Timepoint: Brain relaxation score will be opened during dural opening and before dural closure. Renal parameters will be assessed preoperatively,on postoperative day 1 and day 5, coagulation profile will be assessed preoperatively and 1hour after the surgery, urinary TIMP2-IGFBP7 will be assessed preoperatively and at 1hour and 24 hours after surgery.	—

Measure

Time frame

Brain relaxation score, renal parameters and coagulation profile, urinary TIMP2-IGFBP7Timepoint: Brain relaxation score will be opened during dural opening and before dural closure. Renal parameters will be assessed preoperatively,on postoperative day 1 and day 5, coagulation profile will be assessed preoperatively and 1hour after the surgery, urinary TIMP2-IGFBP7 will be assessed preoperatively and at 1hour and 24 hours after surgery.

—

Countries

India

Contacts

Public ContactNaveen Vivek S

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH (JIPMER)

srinianaes@yahoo.co.in9626493045

Outcome results

None listed

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