Skip to content

Comparison of Isotonic Balanced Crystalloids versus 0.9% Saline on Hyperchloremia and Acid-Base Balance during Elective Supratentorial Craniotomy: A Randomized Controlled Trial

Comparison of Isotonic Balanced Crystalloids versus 0.9% Saline on Hyperchloremia and Acid-Base Balance during Elective Supratentorial Craniotomy: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260423002
Enrollment
80
Registered
2026-04-23
Start date
2026-04-21
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Hyperchloremia and iatrogenic metabolic acidosis in patients undergoing elective supratentorial craniotomy for brain tumors. Balanced Salted Solution, Crystalloids, Hyperchloremia, Acid-Base Balance, Supratentorial Craniotomy

Interventions

Patients will receive an isotonic balanced crystalloid solution (Top Balance) containing 98 mEq/L of chloride with acetate and gluconate buffers. The fluid will be administered intravenously to mainta
Experimental Drug,Active Comparator Drug
Isotonic Balanced Crystalloid Solution,Normal Saline

Sponsors

Sawanpracharak Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 65 years. 2. Physical status classification according to the American Society of Anesthesiologists (ASA) Class I, II, or III (with stable clinical conditions). 3. Patients scheduled for elective supratentorial craniotomy. 4. Anticipated surgical duration of more than 3 hours to ensure sufficient fluid administration for observable biochemical changes. 5. Patients who have provided voluntary written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with pre-existing renal dysfunction, defined as a serum creatinine level more than 1.5 mg/dL or an estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2. 2. Patients with severe pre-operative electrolyte imbalances, specifically a baseline serum chloride level more than 110 mEq/L or less than 95 mEq/L. 3. Patients diagnosed with severe heart failure or advanced liver cirrhosis. 4. Patients undergoing emergency surgery with hemodynamic instability or those requiring massive blood transfusions. 6. Patients who are pregnant.

Design outcomes

Primary

MeasureTime frame
Incidence of Metabolic Acidosis Baseline before surgery, immediately after completion of surgery, and at 24 hours post-operatively Assessment of acid-base status through arterial blood gas analysis including pH, serum bicarbonate levels, and base excess

Secondary

MeasureTime frame
Incidence of Hyperchloremia Baseline before surgery, at the end of surgery, and 24 hours after surgery Serum chloride levels measured by central laboratory,Renal function Baseline before surgery, at the end of surgery, and 24 hours after surgery Changes in Serum Creatinine levels,Acute Kidney Injury Baseline before surgery, at the end of surgery, and 24 hours after surgery Incidence of Acute Kidney Injury based on KDIGO criteria,Brain Relaxation Score During surgery at the time of dura opening Assessment by neurosurgeon using a 4 point scale at the time of dura opening,Serum Electrolyte variation Baseline before surgery, at the end of surgery, and 24 hours after surgery Serum Sodium and Potassium

Countries

Thailand

Contacts

Public ContactChompoonik Jiemjitpolchai

Department of Anesthesiology, Sawanpracharak Hospital, Nakhonsawan, Thailand

chompoonik.jiem@gmail.com0619492635

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026