Trial · NCT01401647

Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia

NCT01401647, Phase 3, Completed, University of Washington; results first posted 2017-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia. Trials, record NCT01401647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01401647

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Trial

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

Title: Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
NCT number: NCT01401647
Status: Completed
Phases: Phase 3
Enrollment: 3,024 participants, actual
Lead sponsor: University of Washington
Conditions: Cardiac Arrest
Interventions: amiodarone, Lidocaine, Normal saline
First posted: 2011-07-25
Last updated: 2017-04-17
Results first posted: 2017-01-30

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 Who Survive From the Time of Cardiac Arrest to Hospital Discharge	Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.	Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.
Secondary	Number of Participants Scoring at or Below a 3 on the MRS Scale	Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.	Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead

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 Who Survive From the Time of Cardiac Arrest to Hospital Discharge	Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.	The primary objective is to determine if survival to hospital discharge is improved with early therapeutic administration of IV amiodarone (PM101) compared to placebo.The secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of Lidocaine vs placebo; PM101 vs lidocaine.	participants	NUMBER
SECONDARY	Number of Participants Scoring at or Below a 3 on the MRS Scale	Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.	MRS as a secondary outcome is not available on all patients that we have survival for.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Units
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge	Amiodarone	237	participants
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge	Lidocaine	233	participants
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge	Normal Saline	222	participants
Number of Participants Scoring at or Below a 3 on the MRS Scale	Amiodarone	182	Participants
Number of Participants Scoring at or Below a 3 on the MRS Scale	Lidocaine	172	Participants
Number of Participants Scoring at or Below a 3 on the MRS Scale	Normal Saline	175	Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Amiodarone	972
Overall Study	STARTED	Lidocaine	993
Overall Study	STARTED	Normal Saline	1,059
Overall Study	COMPLETED	Amiodarone	968
Overall Study	COMPLETED	Lidocaine	985
Overall Study	COMPLETED	Normal Saline	1,056
Overall Study	NOT COMPLETED	Amiodarone	4
Overall Study	NOT COMPLETED	Lidocaine	8
Overall Study	NOT COMPLETED	Normal Saline	3

Source ClinicalTrials.gov

Adverse events15

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
other	Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	Amiodarone	202	972
other	Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	Lidocaine	209	993
other	Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	Normal Saline	184	1,059
other	Hypotension requiring vasopressors	Cardiac disorders	Amiodarone	118	972
other	Hypotension requiring vasopressors	Cardiac disorders	Lidocaine	114	993
other	Hypotension requiring vasopressors	Cardiac disorders	Normal Saline	102	1,059
other	Rearrest	Cardiac disorders	Amiodarone	57	972
other	Rearrest	Cardiac disorders	Lidocaine	76	993
other	Rearrest	Cardiac disorders	Normal Saline	60	1,059
other	Seizures or potential seizures	Nervous system disorders	Amiodarone	35	972

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Amiodarone
Total, all-cause mortality	Lidocaine
Total, all-cause mortality	Normal Saline
Total, other adverse events	Amiodarone	515	972
Total, other adverse events	Lidocaine	548	993
Total, other adverse events	Normal Saline	476	1,059
Total, serious adverse events	Amiodarone	0	972
Total, serious adverse events	Lidocaine	0	993
Total, serious adverse events	Normal Saline	0	1,059

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27043165	DERIVED	PubMed
28904070	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01HL077863	Resuscitation Outcomes Consortium (ROC) Data Coordinating Center	MAY, SUSANNE	UNIVERSITY OF WASHINGTON	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2004 to 2015

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT01401647

GET https://conductscience.org/api/trials/v1/NCT01401647/registered

API reference For AI assistants