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A clinical trial to compare the effect of two different intravenous replacement fluid in patient getting operated for brain tumors

To study the effect on serum electrolytes on patients undergoing elective craniotomy for supratentorial brain tumors using Plasmalyte and Normal Saline as intravenous replacement fluid

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042837
Enrollment
80
Registered
2022-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Health Condition 1: C700- Malignant neoplasm of cerebral meninges Health Condition 2: C710- Malignant neoplasm of cerebrum, except lobes and ventricles Health Condition 3: C711- Malignant neoplasm of frontal lobe Health Condition 4: C714- Malignant neoplasm of occipital lobe Health Condition 5: C713- Malignant neoplasm of parietal lobe Health Condition 6: C712- Malignant neoplasm of temporal lobe Health Condition 7: O- Medical and Surgical

Interventions

Intervention1: Plasmalyte: Plasmalyte infusion used as loading and maintainance fluid given through intravenous route as per requirement upto 48 hours post surgery. Control Intervention1: Normal salin

Sponsors

RIMS Ranchi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: all patients aged between 18 to 60 years undergoing elective craniotomy for supratentorial brain tumors

Exclusion criteria

Exclusion criteria: 1. patients not willing to consent 2. patients with renal dysfunction 3. patients with severe electrolyte imbalance 4. patients with hypersensitivity to plasmalyte 5. patients with hemodynamic instability

Design outcomes

Primary

MeasureTime frame
change in electrolytes in arterial blood gas samplesTimepoint: 1. After induction 2. At the time of Dural opening 3. 1 hour after dural opening 4. At skin closure 5. 1 hour post operatively 6. 24 hours postoperatively 7. 48 hours postoperatively

Secondary

MeasureTime frame
Hyperchloremic metabolic acidosis Acute kidney injury Timepoint: 1. After induction till 48 hours post operatively 2. Up to 48 hours based on RIFLE criteria

Countries

India

Contacts

Public ContactDr Ravi Murmu

Rajendra Institute of Medical Sciences

drsanjayaiims2012@gmail.com

Outcome results

None listed

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