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Isotonic bicarbonate vs. balanced salt solution as volume replacing fluid in patients with severe amount of acid in blood: a randomized control trial

Isotonic bicarbonate vs. Balanced Salt Solution as resuscitation fluid in patients with severe metabolic acidosis: a randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035065
Enrollment
156
Registered
2021-07-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems

Interventions

Intervention1: Isotonic bicarbonate 1.3% fluid: 10 ml/kg bolus as resuscitation maximum 2 times, f/b 5 ml/kg aliquots if hypovolemic over initial 24 hours of emergency admission Control Intervention1:

Sponsors

AIIMS new delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i) 18 years of age or above, ii) pH =2, v) lactate >= 2 mmol/litre requiring fluid resuscitation

Exclusion criteria

Exclusion criteria: PaCO2 >=45 mm Hg, known chronic kidney disease (CKD) stage >=IV or congestive cardiac failure (CHF) with hypervolemia (as seen on ultrasound and echocardiography), pregnant, already on some form of bicarbonate therapy, unknown poisoning with suspected external acid ingestion. Study design : Prospective randomized control trail (RCT)

Design outcomes

Primary

MeasureTime frame
Difference of lactate clearance (LC) at 6 hours, between isotonic bicarbonate and plasmalyte-A group, considering all patients. Timepoint: measuring lactate clearance in two groups at specified time points i.e. 2 hours, 6 hours, 12 hours and at 24 hours after admission

Secondary

MeasureTime frame
change of base excessTimepoint: 2,6,12,24 hours;LCTimepoint: 2,12,24 hours;mortalityTimepoint: 24 hours;pH, osmolarity changesTimepoint: 2,6,12,24 hours;renal replacement therapyTimepoint: within 24 hours;serum electrolytes comparisonTimepoint: 2,6,12,24 hours;vasoactive-inotropic scoreTimepoint: 2,6,12,24 hours

Countries

India

Contacts

Public ContactAvishek Roy

Anesthesia, AIIMS, New Delhi

k.punit@yahoo.com09873106516

Outcome results

None listed

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