Trial Outcomes & Findings for Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy (NCT NCT01172353)

NCT ID: NCT01172353

Last Updated: 2014-02-19

Results Overview

rise in serum creatinine \>0,5mg/dl

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 301 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2014-02-19

Participant Flow

Participant milestones

Measure	Sodium Bicarbonate hydration with sodium bicarbonate sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours	Saline hydration with saline 1ml/Kg/h for 6 hours saline: hydration with saline 1ml/Kg/h for 6 hours
Overall Study STARTED	150	151
Overall Study COMPLETED	150	151
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

Baseline characteristics by cohort

Measure	Sodium Bicarbonate n=150 Participants hydration with sodium bicarbonate sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours	Saline n=151 Participants hydration with saline 1ml/Kg/h for 6 hours saline: hydration with saline 1ml/Kg/h for 6 hours	Total n=301 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 12 • n=5 Participants	64.5 years STANDARD_DEVIATION 12 • n=7 Participants	64.3 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	38 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	104 Participants n=5 Participants	113 Participants n=7 Participants	217 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	140 Participants n=5 Participants	140 Participants n=7 Participants	280 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	150 participants n=5 Participants	151 participants n=7 Participants	301 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

rise in serum creatinine >0,5mg/dl

Outcome measures

Measure	Sodium Bicarbonate n=150 Participants hydration with sodium bicarbonate sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours	Saline n=151 Participants hydration with saline 1ml/Kg/h for 6 hours saline: hydration with saline 1ml/Kg/h for 6 hours
Contrast-induced Nephropathy	6.1 percentage of contrast nephropaty	6.0 percentage of contrast nephropaty

SECONDARY outcome

Timeframe: During hospitalization

Outcome measures

Measure	Sodium Bicarbonate n=150 Participants hydration with sodium bicarbonate sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours	Saline n=151 Participants hydration with saline 1ml/Kg/h for 6 hours saline: hydration with saline 1ml/Kg/h for 6 hours
Dialysis During Hospitalization	0 participants	0 participants

Adverse Events

Sodium Bicarbonate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

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

Vitor Osório Gomes, MD, PhD

Hospital Sao Lucas

Phone: 55 51 33203494

Email: pesquisa@cardiarte.com.br

Results disclosure agreements

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