Trial · NCT01467466

Prevention of Serious Adverse Events Following Angiography

NCT01467466, Phase 3, Completed, VA Office of Research and Development; results first posted 2018-11-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prevention of Serious Adverse Events Following Angiography. Trials, record NCT01467466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01467466

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Prevention of Serious Adverse Events Following Angiography
NCT number: NCT01467466
Status: Completed
Phases: Phase 3
Enrollment: 5,177 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Acute Renal Failure, Kidney Disease, Coronary Artery Disease
Interventions: IV isotonic saline, IV isotonic bicarbonate, N-acetylcysteine, Placebo
First posted: 2011-11-08
Last updated: 2025-11-05
Results first posted: 2018-11-09

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.	Within 90 days following angiography	Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.
Primary	Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.	Within 90 days following angiography	Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.	Within 90 days following angiography		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.	Within 90 days following angiography		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.	Sodium Bicarbonate	111	Participants
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.	Saline	116	Participants
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.	N-Acetylcysteine (NAC)	115	Participants
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.	Placebo	112	Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Saline & oral placebo	1,300
Overall Study	STARTED	Saline & oral N-acetylcysteine	1,292
Overall Study	STARTED	Bicarbonate & oral placebo	1,294
Overall Study	STARTED	Bicarbonate & oral N-acetylcysteine	1,291
Overall Study	COMPLETED	Saline & oral placebo	1,191
Overall Study	COMPLETED	Saline & oral N-acetylcysteine	1,188
Overall Study	COMPLETED	Bicarbonate & oral placebo	1,190
Overall Study	COMPLETED	Bicarbonate & oral N-acetylcysteine	1,203
Overall Study	NOT COMPLETED	Saline & oral placebo	109
Overall Study	NOT COMPLETED	Saline & oral N-acetylcysteine	104

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events2,988

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Atrial Fibrillation	Cardiac disorders	IV isotonic saline & oral placebo	0	1,300	0
other	Atrial Fibrillation	Cardiac disorders	IV isotonic saline & oral N-acetylcysteine	0	1,292	0
other	Atrial Fibrillation	Cardiac disorders	IV isotonic bicarbonate & oral placebo	1	1,294	1
other	Atrial Fibrillation	Cardiac disorders	IV isotonic bicarbonate & oral N-acetylcysteine	0	1,291	0
other	Cardiac Failure Congestive	Cardiac disorders	IV isotonic saline & oral placebo	0	1,300	0
other	Cardiac Failure Congestive	Cardiac disorders	IV isotonic saline & oral N-acetylcysteine	1	1,292	1
other	Cardiac Failure Congestive	Cardiac disorders	IV isotonic bicarbonate & oral placebo	0	1,294	0
other	Cardiac Failure Congestive	Cardiac disorders	IV isotonic bicarbonate & oral N-acetylcysteine	0	1,291	0
other	Palpitations	Cardiac disorders	IV isotonic saline & oral placebo	1	1,300	1
other	Palpitations	Cardiac disorders	IV isotonic saline & oral N-acetylcysteine	0	1,292	0

1 to 10 of 2,988Source ClinicalTrials.gov

See all 2,988 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IV isotonic saline & oral placebo	28	1,300
Total, all-cause mortality	IV isotonic saline & oral N-acetylcysteine	40	1,292
Total, all-cause mortality	IV isotonic bicarbonate & oral placebo	33	1,294
Total, all-cause mortality	IV isotonic bicarbonate & oral N-acetylcysteine	28	1,291
Total, other adverse events	IV isotonic saline & oral placebo	61	1,300
Total, other adverse events	IV isotonic saline & oral N-acetylcysteine	158	1,292
Total, other adverse events	IV isotonic bicarbonate & oral placebo	83	1,294
Total, other adverse events	IV isotonic bicarbonate & oral N-acetylcysteine	170	1,291
Total, serious adverse events	IV isotonic saline & oral placebo	941	1,300
Total, serious adverse events	IV isotonic saline & oral N-acetylcysteine	1,040	1,292

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29130810	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
N-Acetylcysteine (NAC) vs Placebo: Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.	Trial comparisons
Sodium Bicarbonate vs Saline: Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01467466

GET https://conductscience.org/api/trials/v1/NCT01467466/events?page=2

API reference For AI assistants