NCT02821156

Brief Summary

This is a prospective, observational, multicenter study conducted during 1 year in adult and paediatric intensive care units equipped with the EZ-KINOX™ system. A maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial Hypertension (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™ system was planned to be included. The study is strictly non-interventional with the aim of describing current practices and therefore did not affect the patient usual management.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

May 20, 2016

Last Update Submit

June 29, 2016

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments

    Data collected by questionnaire

    Through iNO administration, an average of 4 days

Secondary Outcomes (4)

  • Profile of patients: age, gender, disease characteristics.

    1 day

  • Number and percentage of patients with adverse events

    During iNO administration, an average of 4 days

  • Number and percentage of patients with adverse drug reaction

    From 1h after the end of iNO administration up to 28 days after ICU discharge

  • Investigator's opinion regarding EZ-KINOX use

    Through iNO administration, an average of 4 days

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with PAH associated with heart surgery or PPHN

You may qualify if:

  • Newborn \> or = to 34 weeks gestational age suffering from hypoxic respiratory failure with pulmonary hypertension (France only) or patient presenting post-operative pulmonary hypertension associated with cardiac surgery (France and Belgium) · Patient treated with iNO delivered with EZ-KINOX™

You may not qualify if:

  • Newborn dependent on a right-to-left shunt or with a "malignant" left-right arterial canal
  • Newborn with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Cliniques Universitaires ST Luc

Brussels, 1200, Belgium

Location

CHU Sart TILMAN

Liège, Belgium

Location

Hôpital Pitié-Salpêtrière

Paris, Cedex 13, 75651, France

Location

Hôpital Necker-Enfants Malades

Paris, Paris Cedex, 75743, France

Location

Hôpital Haut-Lévèque

Bordeaux, 33604, France

Location

Hôpital du Bocage Central

Dijon, 21079, France

Location

CHU Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHU de Nantes - Hôpital Laennec

Nantes, 44093, France

Location

Hôpital Hôtel Dieu

Nantes, 44093, France

Location

Hôpital Trousseau

Paris, 75012, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

American Memorial Hospital

Reims, 51092, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Related Publications (2)

  • Pepke-Zaba J, Higenbottam TW, Dinh-Xuan AT, Stone D, Wallwork J. Inhaled nitric oxide as a cause of selective pulmonary vasodilatation in pulmonary hypertension. Lancet. 1991 Nov 9;338(8776):1173-4. doi: 10.1016/0140-6736(91)92033-x.

    PMID: 1682593RESULT

  • Gaudard P, Barbanti C, Rozec B, Mauriat P, M'rini M, Cambonie G, Liet JM, Girard C, Leger PL, Assaf Z, Damas P, Loron G, Lecourt L, Amour J, Pouard P. New Modalities for the Administration of Inhaled Nitric Oxide in Intensive Care Units After Cardiac Surgery or for Neonatal Indications: A Prospective Observational Study. Anesth Analg. 2018 Apr;126(4):1234-1240. doi: 10.1213/ANE.0000000000002813.

    PMID: 29341967DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen CompoundsOxidesOxygen CompoundsOrganic Chemicals

Study Officials

  • Philippe POUARD, MD

    Hôpital Necker-Enfants Malades

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

July 1, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

BE(2)FR(12)