Risk Potential for Organ Dysfunction Associated With Sodium Bicarbonate Therapy (SBT) in Critically Ill Patients

NCT04953013 | Completed

• 1 other identifier: LM2020046
• Study Type: observational
• Target: 664
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate whether hemodynamic status before SBT contributed to the effect of sodium bicarbonate infusion on the risk of neonatal organ dysfunction and mortality in critically ill patients with early metabolic acidosis in ICU.

Conditions

Metabolic Acidosis; Critically Ill Patients; Organ Dysfunction

Outcome Measures

Primary Outcomes (1)

• newly developed or exacerbated organ dysfunction

  We defined a composite of newly "developed or exacerbated organ dysfunction" (d/eOD) as a net increase in Sequential Organ Failure Assessment (SOFA) score ≥2 of at least one organ within 7 days of ICU admission over the baseline (SOFA score in the first 24 hours).

  The duration of the database covers from June 2001 to October 2012.

Study Arms (2)

sodium bicarbonate group

Sodium bicarbonate was initiated within 48 hours after ICU admission.

Drug: sodium bicarbonate

non-sodium bicarbonate group

Patients were not infused with sodium bicarbonate.

Interventions

sodium bicarbonate DRUG

Drug exposure

sodium bicarbonate group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We obtained data from the MIMIC-III. The newest version of MIMIC-III, v. 1.4, integrates 61,532 patients admitted to the ICUs of Beth Israel Deaconess Medical Center in Boston, Massachusetts.

You may qualify if:

• (1) pH≤7.3; (2) BE≤-8, or HCO3- \< 20 mmol/L if BE was missing; and (3) PaCO2\< 50 mmHg, or without chronic obstructive pulmonary disease (COPD) in discharge diagnoses if PaCO2 was unavailable.

You may not qualify if:

• (1) age 16 or under; (2) diabetes insipidus ; (3) comorbidity of peripheral paralysis; (4) ICU stay over 100 days; (5) SBT was initiated before ICU admission , later than 48 hours after ICU admission or after a record of order for renal replacement therapy (RRT); and (6) death within the first 24 hours after ICU admission.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Critical Care Medicine Department

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Acidosis

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 7, 2021
• Study Start: August 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)