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Sodium Bicarbonate for the Treatment of Severe Metabolic Acidosis With Moderate or Severe Acute Kidney Injury in ICU (BICARICU-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010630
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Severe metabolic acidemia in the critically ill (pH equal or less than 7.20; PaCO2 equal or less than 45mmHg and bicarbonate concentration equal or less than of 20 mmol/l) is associated with a 50% rate of day 28 mortality. Moderate to severe acute kidney injury is a frequent cause of metabolic acidemia in the critically ill. When both severe metabolic acidemia and moderate to severe acute kidney injury are observed, day 28 mortality is approximatively 55-60%. Severe acidemia has been shown to be a biomarker of severity but may also contribute by itself to outcome. Investigators recently performed a multiple center randomised clinical trial (BICARICU-1) that suggests that sodium bicarbonate infusion titrated to maintain the pH equal or more than 7.30 is associated with a higher survival rate (secondary endpoint) in patients presenting both severe metabolic acidemia and moderate to severe acute kidney injury patients. Whether sodium bicarbonate infusion may improve long term survival (Day 90, primary outcome) in these severe acute kidney injury patients is currently unknown.

Condition or disease Intervention/treatment Phase
Metabolic Acidosis Acute Kidney Injury Drug: Sodium bicarbonate infusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Sodium Bicarbonate for the Treatment of Severe Metabolic Acidosis With Moderate or Severe Acute Kidney Injury in the Critically Ill: a Randomized Clinical Trial
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: control group
The physicians will resuscitate the patients according to the current critical care medicine guidelines.
Experimental: Sodium bicarbonate group
Patients randomly assigned to bicarbonate group will receive intravenous 4.2% sodium bicarbonate titrated from 125ml to 250ml in 30min at physician's discretion to target a pH equal or above 7.30. Bicarbonate infusion will be repeated up to 1000ml per 24h. Arterial blood gases will be repeated from 3 to 6 times during the first 24h at physician's discretion
Drug: Sodium bicarbonate infusion

Patients randomly assigned to bicarbonate group will receive intravenous 4.2% sodium bicarbonate titrated from 125ml to 250ml in 30min at physician's discretion to target a pH equal or above 7.30. Bicarbonate infusion will be repeated up to 1000ml per 24h. Arterial blood gases will be repeated from 3 to 6 times during the first 24h at physician's discretion.

Bicarbonate infusion recommendations will be as follow: a central line is recommended, infusion will be slow (125-250ml in 30 min, no intravenous push), careful surveillance of metabolic alkalosis, cardiogenic pulmonary edema, kalemia, natremia and calcemia. Repeated arterial blood gases will be suggested to monitor these critically ill patients and physicians will be reinformed of the potential side effects of sodium bicarbonate infusion.





Primary Outcome Measures :
  1. Day 90 all-cause mortality [ Time Frame: Day 90 ]
    Day 90 all cause mortality


Secondary Outcome Measures :
  1. Organ Failure [ Time Frame: up to 7 days after enrolment ]
    Organ failure will be assessed by the SOFA score

  2. Overall fluid balance and solutions intake [ Time Frame: Day 2 ]
    intravenous fluid input (ml) and overall fluid balance (ml) calculated as follow : overall fluid input (ml) minus overall fluid output (ml)

  3. Electrolytes adverse events during the ICU stay [ Time Frame: ICU discharge or Day 28 ]
  4. organ Support Day 90 alive free days [ Time Frame: Day 90 ]
    organ Support : renal replacement, mechanical ventilation and ventilatory free days

  5. Hospital acquired infections [ Time Frame: ICU discharge or Day 28 ]
    Rate of nosocomial infections during the intensive care unit stay

  6. Hospital length of stay [ Time Frame: up to day 180 ]
  7. ICU length of stay [ Time Frame: up to Day 90 ]
  8. Day 28 all-cause mortality [ Time Frame: Day 28 ]
  9. Day 180 all-cause mortality [ Time Frame: Day 180 ]
  10. Quality of Life of participant [ Time Frame: up to Day 180 ]
    Quality of life assessed by the score of EQ5D, ancillary study only in the Montpellier Nimes centers with the centralized post ICU outpatient clinic

  11. functional autonomy of patient [ Time Frame: up to Day 180 ]
    Patient autonomy will be assessed by the The Functional Independence Measure test (FIM score), ancillary study only in the Montpellier Nimes centers with the centralized post ICU outpatient clinic



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged from 18 years old
  • Admitted in the ICU where the BICARICU-2 trial takes place
  • Within 6h before enrolment, the patient MUST present on the same arterial blood gas (the last available before enrollment) the 3 following criteria
  • pH ≤ 7.20
  • Bicarbonatemia < 20 mmol/l
  • AND PaCO2 ≤ 45mmHg
  • Moderate to severe acute kidney injury ("Kidney Disease Improving Global Outcome", KDIGO group of 2 or 3)
  • Within 48h of ICU admission, a total SOFA ≥ 4 OR an arterial lactate concentration ≥ 2 mmol/l
  • Signed informed consent form. According to the French law, considering the severity of the illness, the fact that most of these patients would be unable to consent (sedation or potential delirium) and that their proxies might not be contactable at the time of inclusion, a deferred consent process for emergency situations will be enabled. When deferred consent will be used, written permission to pursue the research will be obtained from the patient or proxy as soon as possible. If this consent is not obtained, the patient's data will not be used and they will be withdrawn from the trial.
  • Subjects must be covered by public health insurance

Exclusion Criteria:

  • Pure respiratory acidosis (defined by pH 7.20, PaCO2 >50 mmHg, bicarbonatemia equal or greater than (PaCO2-40)/10 + 24), digestive or urinary tract proven loss of fluid (equal or greater than 1500ml/24h) with concomitant loss of sodium bicarbonate, stage IV or V chronic kidney disease, proven tubular acidosis, ketoacidosis, exogenous acids poisoning (aspirin, methanol, ), PaCO2 > 45 mmHg and spontaneous breathing, sodium bicarbonate infusion or renal replacement therapy within 24h prior to screening prior to screening or imminent in the next 6h.
  • Pregnant or breast feeding patient
  • Patient who is in a dependency or employment with the sponsor or the investigator
  • Patient who was enrolled in another study and who is in the exclusion period for any enrolment in the present study
  • Life expectancy less than 48h
  • Consent refusal from the patient or his/her next of kin and the impossibility to enrol using the emergency procedure
  • Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique)
  • Absence of a French Health Care Insurance coverage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010630


Contacts
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Contact: Boris JUNG, M.D;Ph.D 0467337271 ext +33 b-jung@chu-montpellier.fr

Locations
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France
Service de médecine intensive et réanimation Recruiting
Montpellier, France, 34000
Contact: Boris JUNG, MD PhD    + 33 4 67 33 02 70    b-jung@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04010630    
Other Study ID Numbers: 7754
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected
Time Frame: 12 months after the main publication
Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.

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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
Additional relevant MeSH terms:
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Acute Kidney Injury
Acidosis
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Acid-Base Imbalance
Metabolic Diseases