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Prevention of Renal Failure by Nitric Oxide in Prolonged Cardiopulmonary Bypass.

NCT01802619 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2018-02-13

No results posted yet for this study

Summary

Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion of nitric oxide (NO) during and after the surgical procedure on CPB may protect against endothelium dysfunction and organ failure caused by plasma-Hb induced NO scavenging.

Conditions

  • Heart Valve Diseases
  • Heart; Complications, Valve, Prosthesis
  • Cardiac Valve Replacement Complication

Interventions

OTHER

inhaled nitric oxide

Nitric oxide administration will commence at the onset of CPB and last for 24 hours. At the end of 24 hours, inhaled NO will be weaned and discontinued while carefully monitoring hemodynamics for a period of 2-4 hours.

OTHER

inhaled Nitrogen

Standard gas including nitrogen (the vehicle of the Nitric oxide) administration will commence at the onset of CPB and last for 24 hours. At the end of 24 hours, inhaled gases will be weaned and discontinued while carefully monitoring hemodynamics for a period of 2-4 hours.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • lize Xiong, M.D.,Ph.D. · Xijing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-06-30
Completion
2016-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01802619 on ClinicalTrials.gov