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Clinical Trials/EUCTR2017-003714-68-AT
EUCTR2017-003714-68-AT
Active, not recruiting
Phase 1

Effect of Supplemental Oxygen on Perioperative Brain Natriuretic Peptide Concentration in Cardiac Risk Patients - A prospective randomized clinical trial

Medical University of Vienna0 sites260 target enrollmentOctober 6, 2017
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ConditionsEvaluation of the effect of 80% versus 30% supplemental oxygen administration during major abdominal surgery on postoperative brain natriuretic peptide concentration.MedDRA version: 20.0Level: PTClassification code 10059883Term: Fraction of inspired oxygenSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10050322Term: Oxygen supplementationSystem Organ Class: 100000173317Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Evaluation of the effect of 80% versus 30% supplemental oxygen administration during major abdominal surgery on postoperative brain natriuretic peptide concentration.
Sponsor
Medical University of Vienna
Enrollment
260
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 6, 2017
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients over 45 years on age, which fulfill 1 or more of the following 4 criteria undergoing non\-cardiac surgery:
  • •1\.History of coronary artery disease
  • •2\.History of peripheral arterial disease
  • •3\.History of stroke OR
  • •4\.Any of 3 of 7
  • •A)Age \= 70 years
  • •B)Undergoing major surgery
  • •C)History of congestive heart failure
  • •D)History of transient ischemic attack
  • •E)Diabetes and currently taking an oral hypoglycemic agent or insulin

Exclusion Criteria

  • •1\.Symptoms of infection or sepsis
  • •2\.Preoperative inotropic therapy
  • •3\.Patients under ICU treatment
  • •4\.Oxygen dependent patients
  • •5\. History of severe heart failure and/or EF \< 30%

Outcomes

Primary Outcomes

Not specified

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