Clinical trial NCT02831907: Portal Flow Pulsatility as a Risk Factor for Acute Kidney Injury After Cardiac Surgery
Official title: Assessment of Portal Flow Using Bedside Doppler Ultrasonography for the Detection of Portal Pulsatility as a Risk Factor for Acute Kidney Injury in Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: C.Surgical Procedure; Cardiac
Acute Kidney Injury
Postoperative Complications
Right-Sided Heart Failure
Cardio-Renal Syndrome
Keywords: Ultrasonography
Portal vein Doppler
Renal Doppler
Cardio-Intestinal syndrome
Delirium
Renal congestion
Intra-renal hemodynamics
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: The Montreal Health Innovations Coordinating Center (MHICC)
First posted: 2016-07-13
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective or urgent cardiac surgery with the use of cardiopulmonary bypass.

Brief summary: The purpose of this study is to evaluate the possible association between portal vein flow pulsatility and acute kidney injury after cardiac surgery. Participants will undergo assessment of portal vein flow and intra-renal blood flow using bedside Doppler ultrasound before surgery and daily for three days after cardiac surgery.

Detailed description: Acute kidney injury is a frequent complication after cardiac surgery. Venous congestion from right ventricular dysfunction and fluid overload can impair kidney perfusion resulting in the cardio-renal syndrome.

An increase in the variation of blood flow velocity in the portal vein during the cardiac cycle called portal pulsatility is a sign of congestive heart failure. Portal pulsatility occurs when increased central venous pressure results liver venous congestion. The presence of abnormal portal pulsatility could be used as a marker of venous congestions in other organs such as the kidneys. Discontinuous intra-renal vein flow is a risk factor for death or re-hospitalization in heart failure patients and could be seen in patients with portal pulsatility.

Eligibility criteria: Inclusion Criteria:

* 18 years and older.
* Undergoing cardiac surgery with the use of cardiopulmonary bypass
* Able to provide consent.

Exclusion Criteria:

* Chronic renal replacement therapy before the procedure.
* Chronic kidney disease stage 5 defined as a estimated glomerular filtration rate by the MDRD equation (eGFR-MDRD) of 15 mL/min/1,73m2 or less.
* Critical pre-operative state defined as aborted sudden death, preoperative cardiac massage, preoperative ventilation before anaesthetic room, preoperative inotropes or intra-aortic counterpulsation balloon.
* Patients previously diagnosed with a condition interfering with Doppler evaluation of the portal system: Portal vein thrombosis, Cirrhosis.
* Patients with documented AKI before surgery.
* Confirmed or suspected pregnancy.
* Kidney transplant recipients.

Primary outcomes:
measure: Acute kidney injury defined by an increase in serum creatinine of ≥150% of baseline or an elevation of 0.3 mg/dL or more within a contiguous period of 48 hours. (KDIGO criteria)
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Mortality
timeFrame: 30 days after surgery
measure: Duration of intensive care stay
timeFrame: 30 days after surgery
measure: Delirium defined as an Intensive Care Delirium Screening Checklist score of 4 or more.
timeFrame: 7 days after surgery
measure: Composite endpoint of persistent organ dysfunction (POD) plus death at day 3 and 7
timeFrame: 3 days and 7 days after surgery
measure: Severe acute kidney injury (KDIGO stage 2 or more) defined by an increase in serum creatinine of ≥200% of baseline.
timeFrame: 7 days after surgery
measure: Discontinuous blow flow in renal interlobar vessels
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: André Denault, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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