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OpenTrials
Completed

NCT Number: NCT03091166

Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients

Investigation of effect of perioperative Dexmedetomedine administration on mortality, length of ICU and hospital stay, delirium onset, major adverse cardiac and cerebrovascular events, acute kidney injury in cardiac surgery patients.

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Key information

Conditions

Patient Outcome Assessment

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Moscow, 129110, Russia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed agreement
  • Elective surgery
  • Use of CPB

Exclusion criteria

  • Previous prolonged immobilization
  • Reoperation

Treatment and study plan

Dexmedetomidine

Drug

Other names: Dexdor

Primary outcomes

  1. 30DM

    Time frame: 30 days after surgery

    30-day mortality

  2. Delirium

    Time frame: 30 days after surgery

    Postoperative delirium

Secondary outcomes

  1. VIS

    Time frame: 5 days after surgery

    Vasoactive- Inotropic Score

  2. MACCE

    Time frame: 30 days after surgery

    Major adverse cardiac and cerebrovascular events

  3. Subsyndromal delirium

    Time frame: 30 days after surgery

    Subsyndromal postoperative delirium

  4. AKI

    Time frame: 7 days after surgery

    Acute kidney injury

  5. ICU-LOS

    Time frame: 7 days after surgery

    Length of ICU stay

  6. H-LOS

    Time frame: 30 days after surgery

    Hospital length of stay

Sponsors and collaborators

Lead sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Other Gov

Registry information

Official study title

The Effect of Prophylactic Dexmedetomidine Administration on the Outcome in Patients Undergoing Surgery With Cardiopulmonary Bypass

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2017
Registry last updated
Apr 11, 2019

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.

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