Isotonic bicarbonate vs. balanced salt solution as volume replacing fluid in patients with severe amount of acid in blood: a randomized control trial
Not Applicable
- Conditions
- Health Condition 1: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems
- Registration Number
- CTRI/2021/07/035065
- Lead Sponsor
- AIIMS new delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
i) 18 years of age or above, ii) pH <= 7.2 and iii) bicarbonate <=20 meq/liter, iv) Baseline Sequential Organ Failure (SOFA) score >=2, v) lactate >= 2 mmol/litre requiring fluid resuscitation
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference of lactate clearance (LC) at 6 hours, between isotonic bicarbonate and plasmalyte-A group, considering all patients. <br/ ><br> <br/ ><br>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 <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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