Trial Outcomes & Findings for N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patients (NCT NCT00780962)

Last Updated: 2024-10-29

Results Overview

Contrast-induced nephropathy was defined as an increase in serum creatinine level of greater than or equal to 0.5 mg/dL or an increase of 25% above baseline. The primary outcome was measured by the change in serum creatinine level from the pre-radiocontrast baseline to the serum creatinine level measured 48 to 72 hours after radiocontrast administration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

399 participants

Primary outcome timeframe

48-72 hours

Results posted on

2024-10-29

Participant Flow

6,977 patients of 2 Emergency Departments at 2 tertiary care, urban university hospitals (Beth Israel Deaconess Medical Center in Boston, MA and Carolinas Medical Center in Charlotte, NC) were assessed for Eligibility between October 2007 and August 2010.

Participant milestones

Participant milestones
Measure	N-Acetycysteine Group Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.	0.9% Sodium-chloride Group Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
Overall Study STARTED	200	199
Overall Study Second Blood Draw (Outcome Measurement)	185	172
Overall Study COMPLETED	185	172
Overall Study NOT COMPLETED	15	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

399 subjects were enrolled in the study, of whom 357 (89.4%) completed a second blood draw. Reported here the Baseline Creatinine serum level (first value meassured) of the participants who completed the second blood draw.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N-Acetycysteine Group n=200 Participants Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.	0.9% Sodium-chloride Group n=199 Participants Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration	Total n=399 Participants Total of all reporting groups
Age, Continuous	61.5 years n=200 Participants	59.7 years n=199 Participants	60.6 years n=399 Participants
Sex: Female, Male Female	124 Participants n=200 Participants	113 Participants n=199 Participants	237 Participants n=399 Participants
Sex: Female, Male Male	76 Participants n=200 Participants	86 Participants n=199 Participants	162 Participants n=399 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=200 Participants	0 Participants n=199 Participants	1 Participants n=399 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	199 Participants n=200 Participants	199 Participants n=199 Participants	398 Participants n=399 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=200 Participants	0 Participants n=199 Participants	0 Participants n=399 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=200 Participants	0 Participants n=199 Participants	0 Participants n=399 Participants
Race (NIH/OMB) Asian	1 Participants n=200 Participants	2 Participants n=199 Participants	3 Participants n=399 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=200 Participants	0 Participants n=199 Participants	0 Participants n=399 Participants
Race (NIH/OMB) Black or African American	50 Participants n=200 Participants	47 Participants n=199 Participants	97 Participants n=399 Participants
Race (NIH/OMB) White	138 Participants n=200 Participants	142 Participants n=199 Participants	280 Participants n=399 Participants
Race (NIH/OMB) More than one race	0 Participants n=200 Participants	0 Participants n=199 Participants	0 Participants n=399 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=200 Participants	8 Participants n=199 Participants	19 Participants n=399 Participants
Baseline Creatinine	1.0 mg/dL n=185 Participants • 399 subjects were enrolled in the study, of whom 357 (89.4%) completed a second blood draw. Reported here the Baseline Creatinine serum level (first value meassured) of the participants who completed the second blood draw.	0.99 mg/dL n=172 Participants • 399 subjects were enrolled in the study, of whom 357 (89.4%) completed a second blood draw. Reported here the Baseline Creatinine serum level (first value meassured) of the participants who completed the second blood draw.	0.99 mg/dL n=357 Participants • 399 subjects were enrolled in the study, of whom 357 (89.4%) completed a second blood draw. Reported here the Baseline Creatinine serum level (first value meassured) of the participants who completed the second blood draw.

PRIMARY outcome

Timeframe: 48-72 hours

Population: Out of 399 subjects who consented to participate in the study, only 357 (89.4%) had a second blood creatinine levels measurement done between 48 to 72h.

Outcome measures

Outcome measures
Measure	N-Acetycysteine Group n=185 Participants Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.	0.9% Sodium-chloride Group n=172 Participants Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
Number of Participants With Contrast-induced Nephropathy	14 Participants	12 Participants

Adverse Events

N-Acetycysteine Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

0.9% Sodium-chloride Group

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	N-Acetycysteine Group n=200 participants at risk Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.	0.9% Sodium-chloride Group n=199 participants at risk Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
Skin and subcutaneous tissue disorders Itching	0.50% 1/200 • Number of events 1 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.	1.0% 2/199 • Number of events 2 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.
Skin and subcutaneous tissue disorders Flushing	1.5% 3/200 • Number of events 3 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.	1.5% 3/199 • Number of events 3 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.
Skin and subcutaneous tissue disorders Rash	0.50% 1/200 • Number of events 1 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.	0.00% 0/199 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.
Gastrointestinal disorders Nausea	2.0% 4/200 • Number of events 4 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.	2.0% 4/199 • Number of events 4 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.
Gastrointestinal disorders Vomiting	0.50% 1/200 • Number of events 1 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.	1.5% 3/199 • Number of events 3 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/200 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.	0.50% 1/199 • Number of events 1 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.
General disorders Other	1.5% 3/200 • Number of events 3 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.	2.0% 4/199 • Number of events 4 • Study participants were monitored during the infusions. Also, we performed a follow-up telephone call to identify patients who had clinically significant renal injury beyond the 72-hour period. Participants were closely monitored by the clinical team. Infusions were discontinued in the event of symptomatic hypotension requiring treatment, altered mental status, respiratory distress, pulmonary edema, oropharyngeal edema or bronchospasm requiring treatment, severe urticaria or patient discomfort, or any other event considered severe enough by the clinical team treating the patient to require discontinuation.

Additional Information

Nathan I. Shapiro, MD, MPH

Beth Israel Deaconess Medical Center

Phone: 617-754-2323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place