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Vasodilator

Inhaled Nitric Oxide for Cardiac Arrest (iNOCAPA Trial)

Phase 2
Recruiting
Led By Jamie Hutchison, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for study follow-up, approximately 2.5 years.
Awards & highlights

Summary

This trial tests how inhaled nitric oxide affects cardiac arrest patients during CPR, and if it can improve survival.

Who is the study for?
This trial is for children and adults aged 1 day to 80 years who've had a cardiac arrest and are on mechanical ventilation in the ICU. They must be able to start treatment during CPR or within 5 hours after circulation returns. Excluded are those with pre-arrest poor brain function, already on iNO, certain heart conditions, long CPR duration (>45 minutes), known pregnancy, or terminal illness.
What is being tested?
The study tests if inhaling nitric oxide (iNO) helps patients during or just after a cardiac arrest compared to a sham (fake treatment). It's randomized and double-blind, meaning neither the participants nor the researchers know who gets real iNO until after the results are collected.
What are the potential side effects?
While specific side effects of inhaled nitric oxide aren't listed here, it can generally cause issues like headache, dizziness, nausea or vomiting. In some cases, it might affect blood pressure or breathing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for study follow-up, approximately 2.5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and for study follow-up, approximately 2.5 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Drug Procedural Feasibility
Secondary study objectives
Monitor masking and unmasking events
Monitor recruitment rate
Monitor time to randomization of eligible patients
+1 more
Other study objectives
Blood protein biomarkers
Cerebral performance category score
Quality of Life Score
+3 more

Side effects data

From 2011 Phase 2 & 3 trial • 21 Patients • NCT00945529
30%
Pleural effusion requiring drainage
22%
prolonged hospital stay due to infection
17%
Prolonged hospital stay due to pleural effusion
4%
Prolonged hospital stay due to seizures
4%
Prolonged hospital stay due to SVT
100%
80%
60%
40%
20%
0%
Study treatment Arm
No Intervention/ Historical Control Group
Intervention

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants with Nitric OxideExperimental Treatment1 Intervention
The mechanical ventilator circuit of the study participants are attached to the inhaled nitric oxide delivery device and nitric oxide is delivered.
Group II: Participants with Sham (no nitric oxide)Placebo Group1 Intervention
The mechanical ventilator circuit of the study participants are attached to the inhaled nitric oxide delivery device but nitric oxide is not delivered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
inhaled nitric oxide (iNO)
2008
Completed Phase 3
~30

Find a Location

Who is running the clinical trial?

Heart and Stroke Foundation of CanadaOTHER
125 Previous Clinical Trials
72,321 Total Patients Enrolled
7 Trials studying Cardiac Arrest
5,663 Patients Enrolled for Cardiac Arrest
The Hospital for Sick ChildrenLead Sponsor
704 Previous Clinical Trials
6,956,837 Total Patients Enrolled
2 Trials studying Cardiac Arrest
494 Patients Enrolled for Cardiac Arrest
Jamie Hutchison, MDPrincipal InvestigatorThe Hospital for Sick Children
1 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Cardiac Arrest
38 Patients Enrolled for Cardiac Arrest

Media Library

Inhaled Nitric Oxide (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT05868109 — Phase 2
Cardiac Arrest Research Study Groups: Participants with Sham (no nitric oxide), Participants with Nitric Oxide
Cardiac Arrest Clinical Trial 2023: Inhaled Nitric Oxide Highlights & Side Effects. Trial Name: NCT05868109 — Phase 2
Inhaled Nitric Oxide (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05868109 — Phase 2
~6 spots leftby Jan 2025
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