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

Primary Purpose

Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Targeted blood-pressure management
Routine blood-pressure management
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Bypass, Off-Pump focused on measuring Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury, Preventive Medicine, Intraoperative Care

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Targeted blood-pressure management

Routine blood-pressure management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of acute kidney injury (AKI) within 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

Classification of AKI within 7 days after surgery
Development of AKI within 7 days after surgery is diagnosed according to the KDIGO criteria
Incidence of delirium within 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).
Duration of mechanical ventilation after surgery
Duration of mechanical ventilation after surgery
Length of stay in intensive care unit (ICU) after surgery
Length of stay in intensive care unit (ICU) after surgery
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery
MACEs within 30 days after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke.
Incidence of non-MACE complications within 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.
All-cause 30-day mortality
All-cause 30-day mortality
2-year overall survival after surgery
2-year overall survival after surgery
2-year major adverse cardiovascular event (MACE)-free survival after surgery
MACEs within 2 years after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke.
Cognitive function in 1- and 2-year survivors
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).
Quality of life in 1- and 2- year survivors: SF-36
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.

Full Information

First Posted
August 9, 2018
Last Updated
May 28, 2023
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03629418
Brief Title
Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury, Preventive Medicine, Intraoperative Care
Keywords
Coronary Artery Bypass, Off-Pump, Intraoperative Hypotension, Acute Kidney Injury, Preventive Medicine, Intraoperative Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
612 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targeted blood-pressure management
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine blood-pressure management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Targeted blood-pressure management
Other Intervention Name(s)
Norepinephrine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Routine blood-pressure management
Other Intervention Name(s)
Phenylephrine and other vasopressors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury (AKI) within 7 days after surgery
Description
Development of AKI within 7 days after surgery is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria
Time Frame
Up to 7 days after surgery
Secondary Outcome Measure Information:
Title
Classification of AKI within 7 days after surgery
Description
Development of AKI within 7 days after surgery is diagnosed according to the KDIGO criteria
Time Frame
Up to 7 days after surgery
Title
Incidence of delirium within 7 days after surgery
Description
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).
Time Frame
Up to 7 days after surgery
Title
Duration of mechanical ventilation after surgery
Description
Duration of mechanical ventilation after surgery
Time Frame
Up to 30 days after surgery
Title
Length of stay in intensive care unit (ICU) after surgery
Description
Length of stay in intensive care unit (ICU) after surgery
Time Frame
Up to 30 days after surgery
Title
Length of stay in hospital after surgery
Description
Length of stay in hospital after surgery
Time Frame
Up to 30 days after surgery
Title
Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery
Description
MACEs within 30 days after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke.
Time Frame
Up to 30 days after surgery
Title
Incidence of non-MACE complications within 30 days after surgery
Description
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.
Time Frame
Up to 30 days after surgery
Title
All-cause 30-day mortality
Description
All-cause 30-day mortality
Time Frame
At 30 days after surgery
Title
2-year overall survival after surgery
Description
2-year overall survival after surgery
Time Frame
Up to 2 years after surgery
Title
2-year major adverse cardiovascular event (MACE)-free survival after surgery
Description
MACEs within 2 years after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke.
Time Frame
Up to 2 years after surgery
Title
Cognitive function in 1- and 2-year survivors
Description
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).
Time Frame
At the end of the 1st and 2nd years after surgery
Title
Quality of life in 1- and 2- year survivors: SF-36
Description
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.
Time Frame
At the end of the 1st and 2nd years after surgery
Other Pre-specified Outcome Measures:
Title
Pain severity within 3 days after surgery: NRS
Description
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.
Time Frame
Up to 3 days after surgery
Title
Daily prevalence of delirium during postoperative days 1-7
Description
Daily prevalence of delirium during postoperative days 1-7
Time Frame
During the first 7 days after surgery
Title
Duration of intraoperative cerebral desaturation (sub-study)
Description
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.
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Xin Wang, MD, PhD
Phone
8610-83572784
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Huang, MD, PhD
Phone
8610-83572460
Email
huanglibd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PHD
Phone
8610-83572784
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Li Huang, MD, PhD
Phone
8610-83572460
Email
huanglibd@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery

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