SODIUM BICARBONATE AND CHRONIC KIDNEY DISEASE PROGRESSION

Recruiting

Conditions: Chronic kidney disease, stage 3 (moderate), (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe),

Registration Number: CTRI/2022/02/039964

Lead Sponsor: INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH KOLKATA

Brief Summary: This study is a single centre , prospective, randomized, parallel group study assessing the efficacy and safety of oral sodium bicarbonate therapy in addition to standard of care compared to standard of care alone in retarding progression of chronic kidney disease stages 3 and 4 with primary outcome of proportion of patients having egfr decline more than 5ml/min or reaching end stage kidney disease and secondary outcomes of changes in nutritional status and adverse events

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 100

Inclusion Criteria

CKD STAGE 3 AND 4 SERUM BICARBONATE LESS THAN 22 MMOL/L STABLE CLINICAL CONDITION AS ASSESSED BY TREATING PHYSICIAN.

Exclusion Criteria

MALIGNANCY MORBID OBESITY COGNITIVE IMPAIRMENT SEPSIS POORLY CONTROLLED BLOOD PRESSURE OVERT CONGESTIVE HEART FAILURE AUTOIMMUNE DISEASE LIMB AMPUTATION POLYCYSTIC KIDNEY DISEASE.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PROPORTION OF PATIENTS HAVING EGFR DECLINE MORE THAN 5 ML/MIN OR END STAGE KIDNEY DISEASE	12 MONTHS

Secondary Outcome Measures

Name	Time	Method
CHANGES IN NUTRITIONAL STATUS	PROPORTION OF PATIENTS WITH ADVERSE EVENTS

Trial Locations

Locations (1): INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH
🇮🇳
Kolkata, WEST BENGAL, India
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH
🇮🇳Kolkata, WEST BENGAL, India
PROF ARPITA RAY CHOUDHURY
Principal investigator
9433254601
lahiri.arpi@gmail.com