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Delirium Reduction by Volatile Anesthesia in Cardiac Surgery (DELICATE)

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ClinicalTrials.gov Identifier: NCT03729011
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Tracking Information
First Submitted Date  ICMJE October 3, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date December 2, 2019
Actual Study Start Date  ICMJE January 9, 2019
Estimated Primary Completion Date December 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Postoperative delirium [ Time Frame: 5 days after surgery ]
Postoperative delirium detection will be managed with Confusion Assessment Method for the ICU (CAM-ICU)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
  • Early postoperative cognitive dysfunction [ Time Frame: 7 days after surgery ]
    We will use Montreal Cognitive Assessment (MoCA) to detect cognitive dysfunction
  • Delirium duration [ Time Frame: 10 days after surgery ]
    number of days
  • Duration of ICU stay [ Time Frame: 30 days ]
    number of days
  • Duration of hospital stay [ Time Frame: 60 days ]
    number of days
  • 30-day all-cause mortality [ Time Frame: 30 days ]
    yes/no
  • One-year all-cause mortality [ Time Frame: 1 year ]
    yes/no
  • Myocardial infarction (MI) [ Time Frame: 30 days ]
    yes/no
  • Stroke [ Time Frame: 30 days ]
    Stroke will be diagnosed by neurologist (yes/no)
  • Seizures [ Time Frame: 30 days ]
    Presence of Seizures (yes/no)
  • Incidence of acute kidney injury (AKI) [ Time Frame: 30 days ]
    According to KDIGO criteria
  • Renal replacement therapy [ Time Frame: 30 days ]
    We will collect data about need of renal replacement therapy (yes/no)
  • Infectious complications [ Time Frame: 30 days ]
    We will collect data about infectious complications: wound infection, mediastinitis, pneumonia, positive blood culture
  • Pain assessment with Behavioral Pain Scale (BPS) [ Time Frame: 5 days after surgery ]
    The BPS is an observational pain scale. It has been validated for use in deeply sedated, mechanically ventilated patients. The BPS contains 3 subscales: facial expression, upper limb movements, and compliance with mechanical ventilation. Each subscale is scored from 1 (no response) to 4 (full response). Therefore, BPS scores range from 3 (no pain) to 12 (maximal pain). A BPS score of 6 or higher is considered to reflect unacceptable pain.
  • Pain assessment with Numerical Rating Scale (NRS) [ Time Frame: 5 days after surgery ]
    A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) or from 0 to 100 (101 point scale) with the understanding that 0 is equal to no pain and 10 or 100 is equal to worst possible pain.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • Early postoperative cognitive dysfunction [ Time Frame: 5 days after surgery ]
    We will use Montreal Cognitive Assessment (MoCA) to detect cognitive dysfunction
  • Duration of ICU stay [ Time Frame: 30 days ]
    number of days
  • Duration of hospital stay [ Time Frame: 60 days ]
    number of days
  • 30-day all-cause mortality [ Time Frame: 30 days ]
    yes/no
  • Myocardial infarction (MI) [ Time Frame: 30 days ]
    Standard diagnostic of MI will be used (yes/no)
  • Type I and type II neurological complications [ Time Frame: 30 days ]
    yes/no
  • Stroke [ Time Frame: 30 days ]
    Stroke will be diagnosed by neurologist (yes/no)
  • Seizures [ Time Frame: 30 days ]
    Presence of Seizures (yes/no)
  • Incidence of acute kidney injury (AKI) [ Time Frame: 30 days ]
    According to KDIGO criteria
  • Renal replacement therapy [ Time Frame: 30 days ]
    We will collect data about need of renal replacement therapy (yes/no)
  • Infectious complications [ Time Frame: 30 days ]
    We will collect data about infectious complications: wound infection, mediastinitis, pneumonia, positive blood culture
  • Pain assessment with Behavioral Pain Scale (BPS) [ Time Frame: 5 days after surgery ]
    Score
  • Pain assessment with Numerical Rating Scale (NRS) [ Time Frame: 5 days after surgery ]
    Score
  • Surgical reoperation because of bleeding [ Time Frame: 10 days after surgery ]
    We will collect data about surgical reoperations for hemostasis (yes/no)
  • High dose inotropic support (inotropic score > 10) [ Time Frame: 5 days after surgery ]
    The inotropic score will be calculated using the following formula: Dobutamine dose (in mcg/kg/min) + Dopamine dose (in mcg/kg/min) + Enoximone dose (in mcg/kg/min) + [Epinephrine dose (in mcg/kg/min) x 100] + [Norepinephrine dose (in mcg/kg/min) x 100]. The highest inotropic score should be collected during operating room or ICU stay.
  • Use of intra-aortic balloon pump [ Time Frame: 10 days ]
    Yes/no
  • Use of ECMO [ Time Frame: 10 days ]
    Yes/no
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Delirium Reduction by Volatile Anesthesia in Cardiac Surgery
Official Title  ICMJE Delirium Reduction by Volatile Anesthesia in Cardiac Surgery: Prospective, Randomized, Single-blinded Study
Brief Summary Parallel group, prospective, randomized, controlled, single-blinded trial. The aim of our study is to test the hypothesis that volatile anesthesia would reduce the incidence of early postoperative delirium in patients undergoing cardiac surgery with CPB as compared to TIVA.
Detailed Description

Delirium is a common neurologic complication after cardiac surgery. Up to 52% of postoperative cardiac surgery patients have delirium. The occurrence of postoperative delirium is associated with worse outcomes, including prolonged length of stay in the ICU and hospital, increased morbidity and mortality, compromised long-term cognitive function and physical ability, and elevated medical care costs. Morbidity of postoperative cognitive dysfunction and delirium mostly common in patients with age more than 60 years.

Several factors including cerebral anoxia, embolism, excessive excitatory neurotransmitter release, systemic inflammatory response, electrolyte and metabolic disorders and hemodynamic changes have been demonstrated to contribute to postoperative neurological dysfunction and delirium.

Previous studies have shown that inhalation anaesthesia and total intravenous anaesthesia (TIVA) may produce different degrees of cerebral protection in these patients. Effects of this two types of anaesthesia in cardiac surgery with CPB remain controversial and much debated.

Inhalation agents depress glucose metabolism, decrease cerebral metabolic rate and oxygen consumption. They also partially uncouple the reactivity of cerebral blood flow to CO2. The changes in cerebral blood flow (CBF) depend on the changes in cerebral metabolism and on direct vasodilatory effects. Cerebral autoregulation is dose-dependently altered. Volatile anaesthetics have been shown to initiate early ischemic preconditioning in neurons, but models of focal brain ischemia suggest it can take 24 h for preconditioning to develop fully.

Propofol is a well-known potentiator of GABAA receptors, it reduces cerebrovascular resistance, CBF and cerebral oxygen delivery during cardiopulmonary bypass. A neuroprotective effect of propofol has been shown to be present in many in vitro and in vivo established experimental models of mild/moderate acute cerebral ischemia.

In recent meta-analysis of 13 randomized controlled studies Chen et al compared the neuroprotective effects of inhalational anesthesia and those of total intravenous anesthesia (TIVA) in cardiac surgery with cardiopulmonary bypass. They have shown that anesthesia with volatile agents appeared to provide better cerebral protection than TIVA. As this meta-analysis had several limitations (small sample size of included studies, high heterogenity, etc.), further studies with larger clinically relevant sample-sizes are needed to demonstrate which anesthetics are more beneficial in terms of brain protection in cardiac surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will be randomly allocated to receive either inhalation anaesthesia or TIVA. Permuted-block randomization will be used to allocate subjects to one of the study groups. Sequentially numbered sealed opaque envelopes will contain the treatment code, to be opened in the morning of surgery. Patients will be unaware of group assignment. All the statistical analyses will be performed by the biostatistician not involved in treatment allocation.
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Delirium
Intervention  ICMJE
  • Drug: Volatile agent
    Patients will receive volatile agent to provide general anaesthesia, including CPB period. Volatile agents will be administered from anesthesia induction to the end of surgery. Concentration (MAC) of volatile agent will be selected by anaesthesiologist according to clinical situation and patient features.
    Other Names:
    • Sevoflurane
    • Desflurane
    • Isoflurane
  • Drug: Propofol
    Patients will receive propofol and no volatile agent. Propofol will be used for induction and maintenance of anesthesia.
Study Arms  ICMJE
  • Active Comparator: Volatile anesthesia group
    Intervention: Drug: Volatile agent
  • Active Comparator: TIVA group
    Intervention: Drug: Propofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
672
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 29, 2022
Estimated Primary Completion Date December 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females > 65 years
  • Written informed consent
  • Cardiac surgery with CPB

Exclusion Criteria:

  • Emergency surgery
  • Surgery on aorta
  • Known allergy to components of anaesthesia
  • Pregnancy
  • Hemodynamically significant stenosis of carotid arteries
  • Parkinson's disease
  • Liver cirrhosis (Child B or C)
  • Current enrollment into another RCT (in the last 30 days)
  • Previous enrollment and randomization into the DELICATE trial
  • Poor language comprehension
  • Preoperative Medications: Anticholinergics (dimedrol, atropine, dramina), antidepressants, antiepileptics, antiparkinson drugs, chemotherapeutic agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vladimir Lomivorotov, PHD 347 60 54 ext 383 vvlom@mail.ru
Contact: Gleb Moroz, PHD 347 60 54 ext 383 Glebmorozz@gmail.com
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729011
Other Study ID Numbers  ICMJE 18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meshalkin Research Institute of Pathology of Circulation
Study Sponsor  ICMJE Meshalkin Research Institute of Pathology of Circulation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Meshalkin Research Institute of Pathology of Circulation
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP