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SODium BICarbonate for Metabolic Acidosis in the ICU (SODa-BIC)

Primary Purpose

Metabolic Acidosis, Shock

Status
Recruiting
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Sodium bicarbonate
5% Dextrose
Sponsored by
Australian and New Zealand Intensive Care Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Acidosis focused on measuring Sodium bicarbonate, Metabolic acidosis, Shock, Clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All the diagnostic criteria of metabolic acidosis below have to be fulfilled within the last 2 hours before randomisation (pH, PaCO2 and BE from the same blood gas), and a vasopressor is being infused continuously at the time of randomization. Adults (≥ 18 years); Receiving a continuous infusion of a vasopressor to maintain mean arterial pressure > 65 mmHg (or a mean arterial pressure target set by the treating clinician); A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour); and Metabolic acidosis, defined as: pH < 7.30; and BE ≤ -4 mEq/L; and PaCO2 ≤ 45 mmHg. Exclusion Criteria: Fulfilled all eligibility criteria greater than 48 hours ago; or Suspected clinically significant digestive or urinary tract loss of sodium bicarbonate (e.g., diarrhoea, ileostomy losses, renal tubular acidosis, or drainage of pancreatic or bile duct); or DKA; or Estimated glomerular filtration rate (eGFR) < 30 mL/min due to chronic kidney disease; or Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed); or Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team); or Severe dysnatraemia (serum Na ≥ 155 mEq/L or < 120 mEq/L); or Hypokalaemia (serum K < 2.5 mEq/L); or Pulmonary oedema with PaO2 / FiO2 < 100; or Hypocalcaemia (iCa < 0.8mmol/L); or Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication); or Pregnancy or breastfeeding; or Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment; or Patients with a life expectancy < 30 days due to a chronic or underlying medical condition; or Considered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease); or Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or Previous enrolment in this study.

Sites / Locations

  • The Austin Hospital
  • The Alfred HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sodium bicarbonate

5% dextrose

Arm Description

Sodium bicarbonate 8.4% (1000 mEq/L) will be diluted in a D5W solution (500 mL bag). For preparation, 300 mL of D5W will be removed and 300 mL of sodium bicarbonate 8.4% added to prepare the bicarbonate solution in a total volume of 500 mL (final concentration: 600 mEq/L).

Standard 500 mL bag of D5W.

Outcomes

Primary Outcome Measures

MAKE30 score
The primary outcome is MAKE30 from the date of randomisation. MAKE30 is defined as a composite of death from any cause, receipt of RRT, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline), all censored at hospital discharge or 30 days, whichever occurs first.

Secondary Outcome Measures

30-day in-hospital mortality
All-cause in-hospital mortality at day 30
Receipt of renal replacement therapy in the first 30 days
Receipt of renal replacement therapy in the first 30 days
Persistent renal dysfunction
Defined as an elevation of the creatinine level to ≥ 200% of baseline
Renal replacement therapy dependence at day 30
Defined by the receipt of any form of renal replacement therapy within ± 10 days of the 30-day time point following randomisation
ICU mortality
All-cause ICU mortality at day 30
Hospital mortality
All-cause hospital mortality at day 90
90-day in-hospital mortality
All-cause mortality at day 90

Full Information

First Posted
January 15, 2023
Last Updated
May 1, 2023
Sponsor
Australian and New Zealand Intensive Care Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05697770
Brief Title
SODium BICarbonate for Metabolic Acidosis in the ICU
Acronym
SODa-BIC
Official Title
SODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit (SODa-BIC): A Multicentre, Randomised, Double-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Australian and New Zealand Intensive Care Research Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial aims to assess if, among adults in the ICU with metabolic acidosis, an infusion of sodium bicarbonate diluted in 5% dextrose, compared with an infusion of 5% dextrose, reduces Major Adverse Kidney Events within 30 days of randomization.
Detailed Description
Background: Metabolic acidosis refers to any process that elevates the concentration of hydrogen ions in the body, and is commonly encountered in critical illness. Lactic acidosis, diabetic ketoacidosis, and hyperchloremic acidosis are major examples seen in the intensive care unit (ICU). Metabolic acidosis may impair cardiac function, and sodium bicarbonate can be used to normalise blood pH. Despite being in common clinical usage, the clinical efficacy of sodium bicarbonate is still uncertain. Previous studies exploring the effects of sodium bicarbonate therapy have been limited and of variable quality. Aim: This trial aims to assess if, among adults in the ICU with metabolic acidosis, an infusion of sodium bicarbonate diluted in 5% dextrose, compared with an infusion of 5% dextrose, reduces Major Adverse Kidney Events within 30 days of randomization. Study Design: Phase 3, international, multicentre, double-blind, randomised clinical trial. Participants: Adult patients (≥ 18 years old), admitted to the ICU within 48 hours, receiving a continuous infusion of a vasopressor drug to maintain a mean arterial pressure > 65 mmHg (or a mean arterial pressure target set by the treating clinician), a dedicated line (central or peripheral) is available (or is about to be made available within 1 hour after randomisation), and within two hours prior to randomisation the participant has metabolic acidosis, defined as: 1) pH < 7.30; 2) BE ≤ -4 mEq/L; and 3) PaCO2 ≤ 45 mmHg. Intervention: Patients will be randomly allocated in a 1:1 ratio to receive two treatments that are commonly used either an infusion of 5% dextrose (D5W) + sodium bicarbonate, or D5W alone, as a comparator. Study drug will be continuously infused targeting a pH 7.30 - 7.35 and a BE ≥ 0 mEq/L. The infusion will be maintained until this target is achieved and continued by titration thereafter for a maximum of 5 hours (to maintain target pH and base excess levels). All other aspects of care will be determined by the treating clinical team, including the use of additional fluid therapy, vasopressors, and other organ support modalities. Open-label sodium bicarbonate bolus infusion is allowed in both groups if clinically indicated. Primary outcome: The primary outcome is the proportion of patients who meet one or more criteria for a major adverse kidney event within 30 days (MAKE 30). MAKE 30 is a composite of death, new receipt of renal-replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥ 200% of the baseline value). All components of MAKE30 will be censored at hospital discharge or 30 days after enrollment, whichever comes first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Acidosis, Shock
Keywords
Sodium bicarbonate, Metabolic acidosis, Shock, Clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly allocated in a 1:1 ratio to receive either an infusion of D5W + sodium bicarbonate, or D5W alone.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
An unblinded research coordinator, pharmacist or nurse not involved in data collection or bedside care will prepare the drug. The bedside nurse who administers the drug, other care providers, all investigators and outcome assessors will be blinded.
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium bicarbonate
Arm Type
Experimental
Arm Description
Sodium bicarbonate 8.4% (1000 mEq/L) will be diluted in a D5W solution (500 mL bag). For preparation, 300 mL of D5W will be removed and 300 mL of sodium bicarbonate 8.4% added to prepare the bicarbonate solution in a total volume of 500 mL (final concentration: 600 mEq/L).
Arm Title
5% dextrose
Arm Type
Active Comparator
Arm Description
Standard 500 mL bag of D5W.
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
Sodium bicarbonate 8.4% will be continuously infused for a maximum of 5 hours. The infusion will start at 100 mL/hr and be kept at this rate until both pH and BE targets are achieved, following which, the infusion rate will be decreased to 25 mL/hr and kept constant at this rate until 5 hours has elapsed since the start of the infusion. At this point, the infusion will be stopped, independently, of the results of arterial blood gas analysis.
Intervention Type
Drug
Intervention Name(s)
5% Dextrose
Intervention Description
5% dextrose will be continuously infused for a maximum of 5 hours. The infusion will start at 100 mL/hr and be kept at this rate until both pH and BE targets are achieved, following which, the infusion rate will be decreased to 25 mL/hr and kept constant at this rate until 5 hours has elapsed since the start of the infusion. At this point, the infusion will be stopped, independently, of the results of arterial blood gas analysis.
Primary Outcome Measure Information:
Title
MAKE30 score
Description
The primary outcome is MAKE30 from the date of randomisation. MAKE30 is defined as a composite of death from any cause, receipt of RRT, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline), all censored at hospital discharge or 30 days, whichever occurs first.
Time Frame
30 days or at hospital discharge (whichever occurs first)
Secondary Outcome Measure Information:
Title
30-day in-hospital mortality
Description
All-cause in-hospital mortality at day 30
Time Frame
30 days or at hospital discharge (whichever occurs first)
Title
Receipt of renal replacement therapy in the first 30 days
Description
Receipt of renal replacement therapy in the first 30 days
Time Frame
30 days or at hospital discharge (whichever occurs first)
Title
Persistent renal dysfunction
Description
Defined as an elevation of the creatinine level to ≥ 200% of baseline
Time Frame
30 days or at hospital discharge (whichever occurs first)
Title
Renal replacement therapy dependence at day 30
Description
Defined by the receipt of any form of renal replacement therapy within ± 10 days of the 30-day time point following randomisation
Time Frame
30 days or at hospital discharge (whichever occurs first)
Title
ICU mortality
Description
All-cause ICU mortality at day 30
Time Frame
30 days or at hospital discharge (whichever occurs first)
Title
Hospital mortality
Description
All-cause hospital mortality at day 90
Time Frame
90 days or at hospital discharge (whichever occurs first)
Title
90-day in-hospital mortality
Description
All-cause mortality at day 90
Time Frame
90 days or at hospital discharge (whichever occurs first)
Other Pre-specified Outcome Measures:
Title
Recurrence of metabolic acidosis in the first 7 days after randomization
Description
Defined as pH < 7.30, BE ≤ -4 mEq/L and PaCO2 ≤ 45 mmHg
Time Frame
7 days after randomization
Title
Incidence and the maximum stage of AKI in the first 7 days after randomization
Description
According to KDIGO criteria
Time Frame
7 days after randomization
Title
Vasopressor-free days at day 30
Description
Defined as 30 - days receiving a continuous infusion of vasopressor [at any time and for any duration]; non-survivors at day 30 will receive 0
Time Frame
30 days or at hospital discharge (whichever occurs first)
Title
Renal replacement therapy-free days at day 30
Description
Defined as 30 - days receiving RRT; non-survivors at day 30 will receive 0
Time Frame
30 days or at hospital discharge (whichever occurs first)
Title
ICU-free days at day 30
Description
Defined as 30 - ICU length of stay; non-survivors at day 30 will receive 0
Time Frame
30 days or at hospital discharge (whichever occurs first)
Title
Hospital-free days at day 90
Description
Defined as 90 -hospital length of stay; non-survivors at day 90 will receive 0
Time Frame
90 days or at hospital discharge (whichever occurs first)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All the diagnostic criteria of metabolic acidosis below have to be fulfilled within the last 2 hours before randomisation (pH, PaCO2 and BE from the same blood gas), and a vasopressor is being infused continuously at the time of randomization. Adults (≥ 18 years); Receiving a continuous infusion of a vasopressor to maintain mean arterial pressure > 65 mmHg (or a mean arterial pressure target set by the treating clinician); A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour); and Metabolic acidosis, defined as: pH < 7.30; and BE ≤ -4 mEq/L; and PaCO2 ≤ 45 mmHg. Exclusion Criteria: Fulfilled all eligibility criteria greater than 48 hours ago; or Suspected clinically significant digestive or urinary tract loss of sodium bicarbonate (e.g., diarrhoea, ileostomy losses, renal tubular acidosis, or drainage of pancreatic or bile duct); or DKA; or Estimated glomerular filtration rate (eGFR) < 30 mL/min due to chronic kidney disease; or Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed); or Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team); or Severe dysnatraemia (serum Na ≥ 155 mEq/L or < 120 mEq/L); or Hypokalaemia (serum K < 2.5 mEq/L); or Pulmonary oedema with PaO2 / FiO2 < 100; or Hypocalcaemia (iCa < 0.8mmol/L); or Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication); or Pregnancy or breastfeeding; or Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment; or Patients with a life expectancy < 30 days due to a chronic or underlying medical condition; or Considered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease); or Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or Previous enrolment in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mairead McNamara
Phone
+613 9903 0513
Email
mairead.mcnamara@monash.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tony Trapani
Phone
+613 9903 0343
Email
tony.trapani@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ary Serpa Neto, PhD
Organizational Affiliation
ANZIC RC, Monash university
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glenn Eastwood
Email
glenn.eastwood@austin.org.au
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Board
Phone
03 9076 8347
Ext
+61
Email
j.board@alfred.org.au

12. IPD Sharing Statement

Plan to Share IPD
No

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SODium BICarbonate for Metabolic Acidosis in the ICU

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