| CTRI Number |
CTRI/2025/10/095613 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to know whether giving sodium bicarbonate, a medicine that reduces blood acidity, can lower the need for dialysis in critically ill patients with severe acidosis and kidney failure |
|
Scientific Title of Study
|
A randomized controlled trial to evaluate the effect of sodium bicarbonate versus placebo on renal replacement therapy requirement in critically ill patients with severe metabolic acidosis and acute kidney injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aravind B Guledagudd |
| Designation |
DM Critical Care Medicine senior resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
ICU 5TH Floor, Trauma and Emergency Care Centre, BMCRI
K R Road, Fort, Bangalore
Bangalore
KARNATAKA
560002
India
Bangalore
KARNATAKA
560002
India |
| Phone |
9731001434 |
| Fax |
|
| Email |
aravindbg2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayakumar H N |
| Designation |
Professor and Head, Department of Critical Care Medicine |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
ICU 5TH Floor, Trauma and Emergency Care Centre, BMCRI
K R Road, Fort, Bangalore
Bangalore
KARNATAKA
India
Bangalore
KARNATAKA
560002
India |
| Phone |
9886504680 |
| Fax |
|
| Email |
viji2751977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayakumar H N |
| Designation |
Professor and Head, Department of Critical Care Medicine |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
ICU 5TH Floor, Trauma and Emergency Care Centre, BMCRI
K R Road, Fort, Bangalore
Bangalore
KARNATAKA
India
Bangalore
KARNATAKA
560002
India |
| Phone |
9886504680 |
| Fax |
|
| Email |
viji2751977@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute, Karnataka, India - 560002 |
|
|
Primary Sponsor
|
| Name |
Department of Critical Care Medicine |
| Address |
5th floor, Trauma and Emergency care centre, Bangalore Medical College and Research Institute, K R Road, Fort, Bangalore, Karnataka - 560002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aravind B Guledagudd |
Bangalore Medical College and Research Institute |
Department of Critical Care Medicine, 5th floor, Trauma and Emergency Care Centre
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9731001434
aravindbg2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTES ETHICS COMMITTEE OF BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
normal saline |
Patients in the placebo group will receive an intravenous infusion of normal saline, given in 125 to 250 mL over 30 minutes at the physician’s discretion, with doses repeated up to a maximum of 1000 mL in 24 hours, always infused over 30 minutes and never as a direct intravenous push.
|
| Intervention |
sodium bicarbonate group |
Patients in the sodium bicarbonate group will receive an intravenous 3.75 percent sodium bicarbonate solution, given in 125 to 250 mL over 30 minutes at the physician’s discretion to raise blood pH to 7.30 or higher, with doses repeated up to a maximum of 1000 mL in 24 hours, always infused over 30 minutes and never as a direct intravenous push.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Within 6 hours before enrolment, the patient must present on the same arterial blood gas (the last available before enrolment) the three following criteria
pH less than or equal to7.20.
Bicarbonate less than or equal to20mmol/L
PaCO2 less than or equal to 45mm Hg.
Moderate-to-severe acute kidney injury (Kidney Disease Improving Global Outcome, group of 2 or 3).
Within 24 hours of ICU admission, a total SOFA more than or equal to 4 or an arterial lactate concentration more than or equal to 2mmol per L.
Signed informed consent form.
|
|
| ExclusionCriteria |
| Details |
Pure respiratory acidosis (defined by pH less than or equal to 7.20, PaCO2 more than or equal to50mm Hg, bicarbonate equal or greater than (PaCO2 minus 40) divided by 10 plus 24).
Digestive or urinary tract proven loss of fluid (equal or greater than 1500mL per 24hours) with concomitant loss of sodium bicarbonate,
Stage IV or V chronic kidney disease,
Proven tubular acidosis.
Ketoacidosis.
Exogenous acids poisoning (aspirin, methanol),
Sodium bicarbonate infusion or renal replacement therapy within 24hours prior to screening or imminent in the next 6hours.
Hyperkalemia more than 6.5 with ECG changes.
Pregnant or breastfeeding patient.
Patient who was enrolled in another study and who is in the exclusion period for any enrolment in the present trial.
Life expectancy less than 24hours.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of sodium bicarbonate therapy compared to placebo on
the proportion of patients requiring renal replacement therapy in critically ill patients with severe metabolic acidosis and KDIGO stage 2–3 acute kidney injury.
|
To evaluate the effect of sodium bicarbonate therapy compared to placebo on
the proportion of patients requiring renal replacement therapy in critically ill patients with severe metabolic acidosis and KDIGO stage 2–3 acute kidney injury at baseline, day 1, day 2, day3, day4, day5, day6, day7, day8, day9, day10, day11, day12, day13 and day 14.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of sodium bicarbonate versus placebo on SOFA score over 5 days & fluid balance on Day 2 in critically ill patients with severe metabolic acidosis & KDIGO stage 2–3 AKI. |
sofa score at baseline, day 1, day2, day3, day4, & day 5
fluid balance at day 1 & day 2
|
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - aravindbg2012@gmail.com
- For how long will this data be available start date provided 02-10-2025 and end date provided 02-10-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Metabolic acidosis is defined as a decrease in blood pH below 7.35 due to reduced serum bicarbonate levels with a compensatory fall in arterial carbon dioxide. It is a common finding in critically ill patients with reported incidence ranging from 8 to 64 percent in intensive care units. Persistent acidemia is linked to poor prognosis with mortality rates reaching up to 57 percent when pH remains below 7.20. Management focuses on treating the underlying cause, optimizing tissue perfusion, and supportive strategies including mechanical ventilation and renal replacement therapy. Because acidemia can impair cellular function, intravenous sodium bicarbonate has been considered as a therapeutic option to raise pH and improve outcomes.
Survey data from North America show that more than two thirds of program directors in nephrology or intensive care report using sodium bicarbonate for acidemia with hyperlactatemia. The BICAR ICU trial demonstrated that sodium bicarbonate infusion improved survival and reduced mortality up to day 28 in patients with severe metabolic acidosis with pH at or below 7.20 and acute kidney injury. It also increased days alive without renal replacement therapy. However, no overall benefit was seen in the unselected population. These findings suggest a possible role of sodium bicarbonate in specific subgroups, and further studies are needed to clarify whether this treatment can improve survival in larger cohorts with severe metabolic acidosis. |