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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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ for study follow-up, approximately 2.5 years.

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

Prolonged hospital stay due to seizures

Prolonged hospital stay due to SVT

100%

80%

60%

40%

20%

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

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