SODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit (SODa-BIC): a Multicentre, Randomised, Double-blind Clinical Trial

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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 for non-intubated patients or PaCO2 ≤ 50 mmHg for intubated patients.

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Grapmians Health
RECRUITING
Ballarat
Flinders Medical Centre
RECRUITING
Bedford Park
Casey Hospital
RECRUITING
Berwick
Cairns Hospital
RECRUITING
Cairns
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Queen Elizabeth II Jubilee Hospital
RECRUITING
Coopers Plains
St Vincent's Hospital Sydney
RECRUITING
Darlinghurst
Footscray Hospital
RECRUITING
Footscray
Frankston Hospital
RECRUITING
Frankston
Canberra Hospital
RECRUITING
Garran
Gosford Hospital
RECRUITING
Gosford
The Austin Hospital
RECRUITING
Heidelberg
Royal Brisbane and Women's Hospital
RECRUITING
Herston
Peninsula Private Hospital
RECRUITING
Langwarrin
The Alfred Hospital
RECRUITING
Melbourne
Epworth
RECRUITING
Richmond
Mater Hospital
RECRUITING
South Brisbane
Sunshine Hospital
RECRUITING
St Albans
Royal Darwin Hospital
RECRUITING
Tiwi
Calvary Mater Newcastle
RECRUITING
Waratah
The Queen Elizabeth Hospital
RECRUITING
Woodville
Princess Alexandra Hopsital
RECRUITING
Woolloongabba
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Wellington Regional Hospital
RECRUITING
Wellington
Oman
Sultan Qaboos Comprehensive Cancer Care and Research Center
RECRUITING
Seeb
Contact Information
Primary
Mairead McNamara
mairead.mcnamara@monash.edu
+613 9903 0513
Backup
Tony Trapani
tony.trapani@monash.edu
+613 9903 0343
Time Frame
Start Date: 2023-04-26
Estimated Completion Date: 2027-06
Participants
Target number of participants: 500
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Australian and New Zealand Intensive Care Research Centre

This content was sourced from clinicaltrials.gov