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Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery

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ClinicalTrials.gov Identifier: NCT03629418
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Study Description
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Brief Summary:
Acute renal injury (AKI) is a common complication after cardiac surgery and is associated with worse outcomes. It is now realized that intraoperative hypotension is an important risk factor for the development of AKI. In a recent randomized controlled trial of patients undergoing major noncardiac surgery, intraoperative individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. The investigators hypothesize that, for patients undergoing off-pump CABG, targeted blood-pressure management during surgery may also reduce the incidence of postoperative AKI.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass, Off-Pump Intraoperative Hypotension Acute Kidney Injury Preventive Medicine Intraoperative Care Drug: Targeted blood-pressure management Drug: Routine blood-pressure management Not Applicable

Detailed Description:
Acute renal injury (AKI) is a common complication after cardiac surgery. In patients undergoing noncardiac surgery, intraoperative hypotension may lead to hypoperfusion of important organs and result in organ injuries such as AKI, myocardial injury, and stroke. The development of organ injuries is associated with wose outcomes including higher 30-day or even 1-year mortality. In a recent randomized controlled trial, patients undergoing major noncardiac surgery received either individualized (systolic blood pressure [SBP] maintained within 10% of the reference level) or standard (SBP maintained above 80 mmHg or within 40% of the reference level) blood-pressure management strategy during surgery. The results showed that individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. Intraoperative hypotension is very common during off-pump coronary artery bypass grafting (CABG) surgery. The investigators hypothesize that, for patients undergoing off-pump CABG, good blood-pressure management with norepinephrine may also reduce the incidence of postoperative AKI. The purpose of this study is to investigate the effect of targeted blood-pressure management during off-pump CABG surgery on the incidence of postoperative AKI.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Targeted Blood-pressure Management on Incidence of Acute Kidney Injury After Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Targeted blood-pressure management
Prophylactic norepinephrine infusion is started at the beginning of anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher during surgery.
 Drug: Targeted blood-pressure management
Prophylactic norepinephrine infusion is started before anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher.
Other Name: Norepinephrine
Active Comparator: Routine blood-pressure management
Phenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery.
 Drug: Routine blood-pressure management
Phenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery.
Other Name: Phenylephrine and other vasopressors


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of acute kidney injury (AKI) within 7 days after surgery [ Time Frame: Up to 7 days after surgery ]
    Development of AKI within 7 days after surgery is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria


Secondary Outcome Measures :
  1. Classification of AKI within 7 days after surgery [ Time Frame: Up to 7 days after surgery ]
    Development of AKI within 7 days after surgery is diagnosed according to the KDIGO criteria

  2. Incidence of delirium within 7 days after surgery [ Time Frame: Up to 7 days after surgery ]
    Development of delirium within 7 days after surgery is assessed with the Confusion Assessment Method (3D-CAM for patients without mechanical ventilation and CAM-ICU for patients with mechanical ventilation).

  3. Duration of mechanical ventilation after surgery [ Time Frame: Up to 30 days after surgery ]
    Duration of mechanical ventilation after surgery

  4. Length of stay in intensive care unit (ICU) after surgery [ Time Frame: Up to 30 days after surgery ]
    Length of stay in intensive care unit (ICU) after surgery

  5. Length of stay in hospital after surgery [ Time Frame: Up to 30 days after surgery ]
    Length of stay in hospital after surgery

  6. Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery [ Time Frame: Up to 30 days after surgery ]
    MACEs within 30 days after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke.

  7. Incidence of non-MACE complications within 30 days after surgery [ Time Frame: Up to 30 days after surgery ]
    Non-MACE complications within 30 days after surgery indicate new-onset medical conditions other than MACEs that produce harmful effects on patients' recovery and required therapeutic intervention.

  8. All-cause 30-day mortality [ Time Frame: At 30 days after surgery ]
    All-cause 30-day mortality

  9. 2-year overall survival after surgery [ Time Frame: Up to 2 years after surgery ]
    2-year overall survival after surgery

  10. 2-year major adverse cardiovascular event (MACE)-free survival after surgery [ Time Frame: Up to 2 years after surgery ]
    MACEs within 2 years after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke.

  11. Cognitive function in 1- and 2-year survivors [ Time Frame: At the end of the 1st and 2nd years after surgery ]
    Cognitive function in 1- and 2-year survivors is assessed with the modified Telephone Interview for Cognitive Status (TICS-m, score ranges from 0 to 40, with higher score indicating better function).

  12. Quality of life in 1- and 2- year survivors: SF-36 [ Time Frame: At the end of the 1st and 2nd years after surgery ]
    Quality of life in 1- and 2-year survivors is assessed with the 36-Item Short Form Health Survey (SF-36). The SF-36 evaluates 8 different domains of quality of life, i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The score of each domain ranges from 0 to 100, with high score indicating better function.


Other Outcome Measures:
  1. Pain severity within 3 days after surgery: NRS [ Time Frame: Up to 3 days after surgery ]
    Pain severity is assessed with the Numeric Rating Scale (NRS, an 11-point scale where 0=no pain and 10=the worst pain) twice daily (8:00-10:00 am, 18:00-20:00 pm) after surgery.

  2. Daily prevalence of delirium during postoperative days 1-7 [ Time Frame: During the first 7 days after surgery ]
    Daily prevalence of delirium during postoperative days 1-7

  3. Duration of intraoperative cerebral desaturation (sub-study) [ Time Frame: During surgery ]
    Duration of cerebral desaturation is monitored by near-infrared spectroscopy. Cerebral desaturation is defined as a decrease of more than 10% from baseline. Performed in part of enrolled patients.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 50 years;
  • Scheduled to undergo off-pump CABG surgery.

Exclusion Criteria:

  • Refuse to participate;
  • Untreated or uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
  • Chronic kidney disease with a glomerular filtration rate < 30 ml/min/1.73 m2 or end-stage renal disease requiring renal-replacement therapy;
  • Inability to communicate during the preoperative period because of coma, profound dementia, language barrier, or end-stage disease;
  • Requirement of vasopressors/inotropics to maintain blood pressure before surgery;
  • Second or emergency surgery;
  • Expected survival of less than 24 hours.
Contacts and Locations
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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): NCT03629418


Contacts
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Contact: Dong-Xin Wang, MD, PhD 8610-83572784 wangdongxin@hotmail.com
Contact: Li Huang, MD, PhD 8610-83572460 huanglibd@163.com

Locations
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China, Beijing
Beijing University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Dong-Xin Wang, MD, PHD    8610-83572784    wangdongxin@hotmail.com   
Contact: Li Huang, MD, PhD    8610-83572460    huanglibd@163.com   
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
More Information
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Publications:

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Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03629418    
Other Study ID Numbers: 2018-118
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Coronary Artery Bypass, Off-Pump
Intraoperative Hypotension
Acute Kidney Injury
Preventive Medicine
Intraoperative Care
Additional relevant MeSH terms:
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Acute Kidney Injury
Hypotension
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Norepinephrine
Cardiotonic Agents
Mydriatics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents