Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization

NCT04530448 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2005006707
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Our overarching goal is to improve the outcomes of critically ill COVID-19 patients with or at risk for development of acute kidney injury (AKI). The objective of this study is to determine the role of a protocol to manage urine alkalization using a simple medication that has been used for a very long time, is safe, and without significant side-effects. We aim to determine the feasibility and safety of a urine alkalinization protocol for the prevention of AKI in patients testing positive for COVID-19.

Conditions

COVID; Coronavirus; Coronavirus Infection; AKI; Acute Kidney Injury

Keywords

Acute Kidney Injury; AKI; COVID-19; Coronavirus; Sodium Bicarbonate

Outcome Measures

Primary Outcomes (2)

• pH

  Primary feasibility outcome will be the proportion of patients treated who achieve \>50% of urine measurements pH ≥= 7.2 over the duration of treatment.

  10 days

• Number of Days Alive Free of Stage 2-3 AKI

  Primary efficacy outcome will be the number of days alive and free of stage 2-3 AKI (up to 28) in each group.

  28 days post-treatment

Secondary Outcomes (3)

• Stage 2-3 AKI

  28 days

• Vent-Free

  28 days

• Hospital-Free

  60 days post-index hospitalization

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of Care treatment

Other: Standard of Care

Sodium Bicarbonate

ACTIVE COMPARATOR

Sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.

Drug: Sodium bicarbonate

Interventions

Sodium bicarbonate DRUG

Sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.

Sodium Bicarbonate

Standard of Care OTHER

Standard of Care treatment

Standard of Care

Eligibility Criteria

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

You may qualify if:

• Confirmed COVID-19 positive
• Admission to ICU or step-down unit
• Age ≥ 18 years old

You may not qualify if:

• Stage 3 AKI by KDIGO criteria
• CKD stage 4-5
• Contraindications to Na bicarbonate therapy (e.g. met. alkalosis, severe heart failure)
• Urine pH \> 7.0

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Medicine Heart & Vascular Institute

Morgantown, West Virginia, 26506, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Coronavirus Infections; Acute Kidney Injury; COVID-19

Interventions

Sodium Bicarbonate; Standard of Care

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Ankit Sakhuja, MD
• Organization: West Virginia University

ankit.sakhuja@hsc.wvu.edu

304.598.6092

Study Officials

• Ankit Sakhuja, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1 (control) will receive standard of care treatment for coronavirus according to institutional protocols. Group 2 (treatment) will receive sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour.

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 28, 2020
• Study Start: October 5, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: December 22, 2023
• Results First Posted: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)