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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05697770




Registration number
NCT05697770
Ethics application status
Date submitted
15/01/2023
Date registered
26/01/2023

Titles & IDs
Public title
SODium BICarbonate for Metabolic Acidosis in the ICU
Scientific title
SODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit (SODa-BIC): a Multicentre, Randomised, Double-blind Clinical Trial
Secondary ID [1] 0 0
ANZIC-RC/ASN001
Universal Trial Number (UTN)
Trial acronym
SODa-BIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Acidosis 0 0
Shock 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sodium bicarbonate
Treatment: Drugs - 5% Dextrose

Experimental: Sodium bicarbonate - 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).

Active comparator: 5% dextrose - Standard 500 mL bag of D5W.


Treatment: Drugs: Sodium bicarbonate
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.

Treatment: Drugs: 5% Dextrose
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MAKE30 score
Timepoint [1] 0 0
30 days or at hospital discharge (whichever occurs first)
Secondary outcome [1] 0 0
30-day in-hospital mortality
Timepoint [1] 0 0
30 days or at hospital discharge (whichever occurs first)
Secondary outcome [2] 0 0
Receipt of renal replacement therapy in the first 30 days
Timepoint [2] 0 0
30 days or at hospital discharge (whichever occurs first)
Secondary outcome [3] 0 0
Persistent renal dysfunction
Timepoint [3] 0 0
30 days or at hospital discharge (whichever occurs first)
Secondary outcome [4] 0 0
Renal replacement therapy dependence at day 30
Timepoint [4] 0 0
30 days or at hospital discharge (whichever occurs first)
Secondary outcome [5] 0 0
ICU mortality
Timepoint [5] 0 0
30 days or at hospital discharge (whichever occurs first)
Secondary outcome [6] 0 0
Hospital mortality
Timepoint [6] 0 0
90 days or at hospital discharge (whichever occurs first)
Secondary outcome [7] 0 0
90-day in-hospital mortality
Timepoint [7] 0 0
90 days or at hospital discharge (whichever occurs first)

Eligibility
Key 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.

1. Adults (= 18 years);
2. 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);
3. A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour); and
4. Metabolic acidosis, defined as:

1. pH < 7.30; and
2. BE = -4 mEq/L; and
3. PaCO2 = 45 mmHg for non-intubated patients or PaCO2 = 50 mmHg for intubated patients.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Fulfilled all eligibility criteria greater than 48 hours ago; or
2. 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
3. DKA; or
4. Estimated glomerular filtration rate (eGFR) < 30 mL/min due to chronic kidney disease; or
5. Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed); or
6. Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team); or
7. Severe dysnatraemia (serum Na = 155 mEq/L or < 120 mEq/L); or
8. Hypokalaemia (serum K < 2.5 mEq/L); or
9. Pulmonary oedema with PaO2 / FiO2 < 100; or
10. Hypocalcaemia (iCa < 0.8mmol/L); or
11. Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication); or
12. Pregnancy or breastfeeding; or
13. 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
14. Patients with a life expectancy < 30 days due to a chronic or underlying medical condition; or
15. Considered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease); or
16. Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or
17. Previous enrolment in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [4] 0 0
Gosford Hospital - Gosford
Recruitment hospital [5] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 0 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [7] 0 0
Cairns Hospital - Cairns
Recruitment hospital [8] 0 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [9] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [10] 0 0
Mater Hospital - South Brisbane
Recruitment hospital [11] 0 0
Princess Alexandra Hopsital - Woolloongabba
Recruitment hospital [12] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [14] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [15] 0 0
Grapmians Health - Ballarat
Recruitment hospital [16] 0 0
Casey Hospital - Berwick
Recruitment hospital [17] 0 0
Footscray Hospital - Footscray
Recruitment hospital [18] 0 0
Frankston Hospital - Frankston
Recruitment hospital [19] 0 0
The Austin Hospital - Heidelberg
Recruitment hospital [20] 0 0
Peninsula Private Hospital - Langwarrin
Recruitment hospital [21] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [22] 0 0
Epworth - Richmond
Recruitment hospital [23] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
0810 - Tiwi
Recruitment postcode(s) [7] 0 0
4870 - Cairns
Recruitment postcode(s) [8] 0 0
4108 - Coopers Plains
Recruitment postcode(s) [9] 0 0
4006 - Herston
Recruitment postcode(s) [10] 0 0
4101 - South Brisbane
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [12] 0 0
5000 - Adelaide
Recruitment postcode(s) [13] 0 0
- Bedford Park
Recruitment postcode(s) [14] 0 0
5011 - Woodville
Recruitment postcode(s) [15] 0 0
3350 - Ballarat
Recruitment postcode(s) [16] 0 0
3806 - Berwick
Recruitment postcode(s) [17] 0 0
3011 - Footscray
Recruitment postcode(s) [18] 0 0
3199 - Frankston
Recruitment postcode(s) [19] 0 0
3084 - Heidelberg
Recruitment postcode(s) [20] 0 0
3910 - Langwarrin
Recruitment postcode(s) [21] 0 0
3004 - Melbourne
Recruitment postcode(s) [22] 0 0
3121 - Richmond
Recruitment postcode(s) [23] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington
Country [4] 0 0
Oman
State/province [4] 0 0
Seeb

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ary Serpa Neto, PhD
Address 0 0
ANZIC RC, Monash university
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mairead McNamara
Address 0 0
Country 0 0
Phone 0 0
+613 9903 0513
Fax 0 0
Email 0 0
mairead.mcnamara@monash.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05697770