Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill

NCT02476253 | Completed Phase 3 DMC

• 1 other identifier: 9260
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to compare the adjunct treatment of metabolic or mixed severe acidosis in the critically ill using Sodium Bicarbonate as a buffer to increase the plasma pH vs no buffering therapy. The study is a randomized multiple center clinical trial with the outcome as a primary endpoint.

Conditions

Metabolic Acidosis

Keywords

acidosis; shock; sodium bicarbonate; renal replacement therapy

Outcome Measures

Primary Outcomes (1)

• Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4

  Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4

  Day 0 to Day 28

Secondary Outcomes (6)

• Evolution of the organ failure scores

  Day 0 to Day 28

• Duration of renal replacement therapy (days)

  Day 0 to Day 28

• Duration of mechanical ventilation and ventilatory free days (days)

  Day 0 to Day 28

• Duration of vasopressors administration (h)

  Day 0 to Day 28

• Hospital acquired infections (incidence)

  Day 0 to Day 28

Study Arms (2)

Intervention

EXPERIMENTAL

Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30

Drug: Sodium Bicarbonate

Control

NO INTERVENTION

No intervention

Interventions

Sodium Bicarbonate DRUG

Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 yo or above,
• Critically ill patient with a SOFA score of 4 or above,
• Lactatemia of 2mmol/l or above, with pH of 7.20 or below and PaCO2 of 45mmHg or below and bicarbonatemia of 20mmol/l or below

You may not qualify if:

• Single respiratory disorder (PaCO2 \> 50 mmHg, Bicarbonatemia equal or higher than (PaCO2-40)/10 + 24
• Acute diarrhea, ileostomy or biliary drainage
• Stage IV kidney failure or chronic dialysis
• Tubular acidosis, ketoacidosis, high anion gap acids poisoning (PEG, aspirin, methanol)
• PaCO2 equal to 45mmHg or above and spontaneous breathing, pregnancy, protected patients, moribund patient (life expectancy of 48h or below)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

DAR St Eloi

Montpellier, 34000, France

Location

Related Publications (39)

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MeSH Terms

Conditions

Acidosis; Shock

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 19, 2015
• Study Start: May 5, 2015
• Primary Completion: May 29, 2017
• Study Completion: May 29, 2017
• Last Updated: May 29, 2024

Record last verified: 2017-06

Locations

FR (1)