Beijing University First Hospital
Beijing, Beijing Municipality, 100034, China
Location status: Recruiting
Location contact
Dong-Xin Wang, MD, PHD
CONTACT
Li Huang, MD, PhD
CONTACT
NCT Number: NCT03629418
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100034, China
Location status: Recruiting
Dong-Xin Wang, MD, PHD
CONTACT
Li Huang, MD, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Norepinephrine
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 names: Phenylephrine and other vasopressors
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
Time frame: Up to 7 days after surgery
Development of AKI within 7 days after surgery is diagnosed according to the KDIGO criteria
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).
Time frame: Up to 30 days after surgery
Duration of mechanical ventilation after surgery
Time frame: Up to 30 days after surgery
Length of stay in intensive care unit (ICU) after surgery
Time frame: Up to 30 days after surgery
Length of stay in hospital 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.
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.
Time frame: At 30 days after surgery
All-cause 30-day mortality
Time frame: Up to 2 years after surgery
2-year overall 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.
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).
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.
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.
Time frame: During the first 7 days after surgery
Daily prevalence of delirium during postoperative days 1-7
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.
Contact information is provided by the study sponsor or research team.
Dong-Xin Wang, MD, PhD
CONTACT
Li Huang, MD, PhD
CONTACT
Peking University First Hospital
Other
Impact of Targeted Blood-pressure Management on Incidence of Acute Kidney Injury After Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial
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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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