Trial Outcomes & Findings for Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization (NCT NCT04530448)

NCT ID: NCT04530448

Last Updated: 2023-12-22

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 3 participants
• Primary outcome timeframe: 10 days
• Results posted on: 2023-12-22

Participant Flow

Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study and data was not collected.

Participant milestones

Measure	Standard of Care Standard of Care treatment Standard of Care: Standard of Care treatment	Sodium Bicarbonate 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: 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.
Overall Study STARTED	3	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Standard of Care Standard of Care treatment Standard of Care: Standard of Care treatment	Sodium Bicarbonate 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: 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.
Overall Study Physician Decision	3	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Standard of Care n=3 Participants Standard of Care treatment Standard of Care: Standard of Care treatment	Sodium Bicarbonate 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: 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.	Total n=3 Participants Total of all reporting groups
Age, Continuous	55 years n=3 Participants	—	55 years n=3 Participants
Sex: Female, Male Female	0 Participants n=3 Participants	0 Participants	0 Participants n=3 Participants
Sex: Female, Male Male	3 Participants n=3 Participants	0 Participants	3 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 10 days

Population: Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study and data was not collected.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 28 days post-treatment

Population: Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study and data was not collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study and data was not collected.

proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study and data was not collected.

Ventilator-free days to 28 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 days post-index hospitalization

Population: Unable to recruit enough subjects to complete the study. Only 3 subjects enrolled. However, those subjects did not complete the study as the PI terminated the study and data was not collected.

Hospital-free days to 60 days

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sodium Bicarbonate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ankit Sakhuja, MD

West Virginia University

Phone: 304.598.6092

Email: ankit.sakhuja@hsc.wvu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place