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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 50 years;

Scheduled to undergo off-pump CABG surgery.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Targeted blood-pressure management

    Drug

    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.

  • Routine blood-pressure management

    Drug

    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.

Treatment groups

612 Participants
are divided into 2 treatment groups
Group A: Targeted blood-pressure managementExperimental treatment 1 intervention
Group B: Routine blood-pressure managementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 7 days after surgery

Secondary outcomes

1

Classification of AKI within 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
2

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).

Time frame
Up to 7 days after surgery
3

Duration of mechanical ventilation after surgery

Duration of mechanical ventilation after surgery

Time frame
Up to 30 days after surgery
4

Length of stay in intensive care unit (ICU) after surgery

Length of stay in intensive care unit (ICU) after surgery

Time frame
Up to 30 days after surgery

Other outcomes

1

Pain severity within 3 days after surgery: NRS

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
2

Daily prevalence of delirium during postoperative days 1-7

Daily prevalence of delirium during postoperative days 1-7

Time frame
During the first 7 days after surgery
3

Duration of intraoperative cerebral desaturation (sub-study)

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

Sponsors and contacts

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