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Trial record 2 of 7 for:    19101265 [PUBMED-IDS]

Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02155868
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Evgeny Fominskiy, MD, PhD, Meshalkin Research Institute of Pathology of Circulation

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Complications Other: Correction rSO2 desaturation. Other: Standard treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cerebral Near-Infrared Spectroscopy Monitoring in High-Risk Cardiac Surgery Patients: A Prospective, Randomised, Single-Blinded Study
Study Start Date : June 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention

Cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C.

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

Other: Correction rSO2 desaturation.

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.


Placebo Comparator: Control
Only cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C during cardiac surgery and the first six hours after it.
Other: Standard treatment
Standard treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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%



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155868


Locations
Russian Federation
Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
Novosibirsk, Novosibirsk Territory, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Vladimir V Lomivorotov, Prof Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology

Publications:

Responsible Party: Evgeny Fominskiy, MD, PhD, Mr, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02155868     History of Changes
Other Study ID Numbers: NIRS-in-CS
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by Evgeny Fominskiy, MD, PhD, Meshalkin Research Institute of Pathology of Circulation:
Cerebral near-infrared spectroscopy monitoring
Postoperative complications
Cardiac surgery

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes