NCT02155868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

2.5 years

First QC Date

May 31, 2014

Last Update Submit

January 25, 2017

Conditions

Postoperative Complications

Keywords

Cerebral near-infrared spectroscopy monitoringPostoperative complicationsCardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative complications

    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.

    Up to 30 day after randomisation

Secondary Outcomes (4)

  • Incidence of major organ morbidity and mortality

    Up to 30 day after randomization

  • Duration of intensive care unit stay

    Up to 30 day after randomization

  • Duration of postoperative hospital stay

    Up to 30 day after randomization

  • Death from all causes at 30 days

    Up to 30 day after randomisation

Other Outcomes (2)

  • Incidence of desaturation episodes

    Intra operative

  • Severity of desaturation episodes

    Intra operative

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Control

PLACEBO COMPARATOR

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

Interventions

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.

Intervention
Standard treatmentOTHER

Standard treatment

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology

Novosibirsk, Novosibirsk Territory, 630055, Russia

Location

Related Publications (6)

  • Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.

    PMID: 17179242BACKGROUND

  • Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Oct;18(5):552-8. doi: 10.1053/j.jvca.2004.07.007.

    PMID: 15578464BACKGROUND

  • Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.

    PMID: 19101265BACKGROUND

  • Fischer GW, Lin HM, Krol M, Galati MF, Di Luozzo G, Griepp RB, Reich DL. Noninvasive cerebral oxygenation may predict outcome in patients undergoing aortic arch surgery. J Thorac Cardiovasc Surg. 2011 Mar;141(3):815-21. doi: 10.1016/j.jtcvs.2010.05.017. Epub 2010 Jun 25.

    PMID: 20579669BACKGROUND

  • Heringlake M, Garbers C, Kabler JH, Anderson I, Heinze H, Schon J, Berger KU, Dibbelt L, Sievers HH, Hanke T. Preoperative cerebral oxygen saturation and clinical outcomes in cardiac surgery. Anesthesiology. 2011 Jan;114(1):58-69. doi: 10.1097/ALN.0b013e3181fef34e.

    PMID: 21178669BACKGROUND

  • Denault A, Deschamps A, Murkin JM. A proposed algorithm for the intraoperative use of cerebral near-infrared spectroscopy. Semin Cardiothorac Vasc Anesth. 2007 Dec;11(4):274-81. doi: 10.1177/1089253207311685.

    PMID: 18270192BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vladimir V Lomivorotov, Prof

    Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

May 31, 2014

First Posted

June 4, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

RU(1)