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Role of soda-bicarbonate in treatment of severe metabolic acidosis in children with severe diarrhoea-dehydration

ROLE OF BICARBONATE DEFICIT CORRECTION IN DIARRHOEA ASSOCIATED SEVERE DEHYDRATION AND METABOLIC ACIDOSIS - AN OPEN LABEL RANDOMIZED CONTROL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018510
Enrollment
60
Registered
2019-04-09
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: A09- Infectious gastroenteritis and colitis, unspecified

Interventions

Intervention1: GROUP B: Children will receive ringer lactate (RL) [Sodium-130 mmol/L, chloride-109 mmol/L, lactate-28 mmol/L, potassium-4 mmol/L, calcium-1.5 mmol/L] as per the WHO protocol for dehydr

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 1 months to less than 12 years. 2. Acute diarrhoea (less than 7 daysâ?? duration) 3. Severe Dehydration (according to WHO criteria) 4. Severe metabolic acidosis (pH less than 7.2 AND/OR bicarbonate less than 15 mEq/L, and PaCO2 less than40 torr) 5. Corrected Non-anion gap metabolic acidosis (Anion Gap:10-16) or If Anion gap is more than 16, but delta Anion Gap/ delta Bicarbonate ratio, less than 1.

Exclusion criteria

Exclusion criteria: 1. Chronic diarrhoea 2. Extra intestinal infection 3. Patient not requiring intravenous fluid therapy 4. Children with Renal tubular acidosis, Acute Kidney injury, Chronic renal disease, Diabetic ketoacidosis, Lactic acidosis, poisoning, In born error of metabolism etc.

Design outcomes

Primary

MeasureTime frame
time taken for resolution of metabolic acidosis, i.e., achieving a pH of 7.3 and/or bicarbonate of more than 15 mEq/L in the two groupsTimepoint: time taken for resolution of metabolic acidosis, i.e., achieving a pH of 7.3 and/or bicarbonate of more than 15 mEq/L in the two groups

Secondary

MeasureTime frame
I. Comparison of time taken for correction of dyselectrolytemias (sodium, potassium, and chloride), if present at admission. II. Comparison of occurrence of III. Comparison of pSOFA scores. IV. Comparison of Vasoactive Inotrope Score (VIS). V. Comparison of length of acute care area stay and total hospital stay. VI. Incidence of adverse events (Hypernatremia, AKI, MOF).Timepoint: Till patient discharge

Countries

India

Contacts

Public ContactProf Arun Baranwal

PGIMER Chandigarh

baranwal1970@gmail.com7766908325

Outcome results

None listed

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