Skip to main content
OpenTrials
Completed

NCT Number: NCT02155868

Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery

Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality used to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared spectroscopy has increasingly been used in perioperative setting of heart surgery and many studies have outlined an increased incidence of postoperative morbidity in patients with significant perioperative reductions in rSO2. Although a relationship between rSO2 reductions and adverse outcomes has been reported, there is not compelling evidence that interventions to correct rSO2 during cardiac surgery lead to improved clinical outcomes.

Hypothesis of the study is that interventions to normalize intraoperatively decreased cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk cardiac surgery patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology

Novosibirsk, Novosibirsk Territory, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

High-risk cardiac surgery patients as determined by at least one of the followings:

  • the age greater than or equal to 75 years on the day of screening;
  • left ventricle ejection fraction less than 35%;
  • use of a preoperative intraaortic balloon pump;
  • combined valve and coronary artery surgery or multiple valve surgery in patients who have congestive heart failure, or renal insufficiency (creatinine clearance < 60 ml/min)

Exclusion criteria

  • refusal of consent

Treatment and study plan

Correction rSO2 desaturation.

Other

Predefined protocol of interventions for correcting rSO2 desaturation (< 60%) during cardiac surgery and the first six hours after it.

In case of rSO2 decrease less than 60% correct:

head position; position of aortic,venous cannulae and central venous catheters; partial pressure of carbon dioxide in arterial blood < 35 mmHg; mean arterial pressure < 60 mmHg; central venous pressure > 10 mmHg; cardiac index < 2.0 l/min/m2; mixed venous oxygen saturation < 60%; hemoglobin < 65 g/L during cardiopulmonary bypass or hemoglobin < 90 g/L after cardiopulmonary bypass; decrease cerebral O2 consumption.

standard treatment

Other

Standard treatment

Primary outcomes

  1. Incidence of postoperative complications

    Time frame: Up to 30 day after randomisation

    This composite outcome includes: myocardial infarction, stroke, delirium, postoperative cognitive dysfunction, wound infection, mediastinitis, mechanical ventilation more than 24 h, arrhythmia, reoperation for bleeding, acute kidney injury, and acute kidney injury requiring dialysis.

Secondary outcomes

  1. Incidence of major organ morbidity and mortality

    Time frame: Up to 30 day after randomization

    This outcome includes: stroke, acute kidney injury requiring dialysis, mechanical ventilation more than 48 h, mediastinitis, reoperation, and death

  2. Duration of intensive care unit stay

    Time frame: Up to 30 day after randomization

  3. Duration of postoperative hospital stay

    Time frame: Up to 30 day after randomization

  4. Death from all causes at 30 days

    Time frame: Up to 30 day after randomisation

Other outcomes

  1. Incidence of desaturation episodes

    Time frame: Intra operative

    Desaturation is defined as level of rSO2 less than 60%.

  2. Severity of desaturation episodes

    Time frame: Intra operative

    Severity is defined as the product of length of time and depth of rSO2 less than 60%

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

Cerebral Near-Infrared Spectroscopy Monitoring in High-Risk Cardiac Surgery Patients: A Prospective, Randomised, Single-Blinded Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2014
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.