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Clinical Trials/NL-OMON50652
NL-OMON50652
Completed
Phase 3

itric Oxide during Cardio Pulmonary Bypass during surgery for congenital heart defects: A Randomised Controlled Trial. - Nitric Oxide during Cardio Pulmonary Bypass in CHD

niversitair Medisch Centrum Utrecht0 sites82 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
82
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •\- All infants and children \< 2 years of age undergoing open heart surgery on CPB
  • •\- Elective cardiac surgery and consent of parents/guardian.

Exclusion Criteria

  • •\- Signs of persistently elevated pulmonary vascular resistance preoperatively
  • •requiring iNO or preoperative use of intravenous drugs involved in the NO
  • •pathway such as GTN, within 48 hours prior to CPB.\- Patient is on ECLS prior to
  • •surgery\- Concurrent known confirmed bacterial sepsis/septic shock, diagnosed
  • •within \<48 hours prior to surgery and being actively treated with antibiotics
  • •at time of surgery (suspected sepsis treated with antibiotics is not an
  • •exclusion criteria unless inotropes are required for treatment of septic shock
  • •at time of surgery)\- Preoperative acute respiratory distress syndrome requiring
  • •HFOV ventilation \<48 hours of surgery\- Patient requires high doses of
  • •vasoactive drugs prior to surgery with an inotrope score \>\=15 met within 24

Outcomes

Primary Outcomes

Not specified

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