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NCT Number: NCT02831907

Portal Flow Pulsatility as a Risk Factor for Acute Kidney Injury After Cardiac Surgery

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.

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Key information

Conditions

C.Surgical Procedure; Cardiac Acute Kidney Injury Cardio-Renal Syndrome Cardiovascular Diseases Confusion Delirium Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Renal Insufficiency Right-Sided Heart Failure Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cardiac surgery

Procedure

All cardiac surgery procedures with the use of cardiopulmonary bypass

Primary outcomes

  1. 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)

    Time frame: 7 days after surgery

    The definition of acute kidney injury is based on the KDIGO guidelines

Secondary outcomes

  1. Mortality

    Time frame: 30 days after surgery

  2. Duration of intensive care stay

    Time frame: 30 days after surgery

  3. Delirium defined as an Intensive Care Delirium Screening Checklist score of 4 or more.

    Time frame: 7 days after surgery

    Intensive Care Delirium Screening Checklist is a validated tool for the screening of delirium in the intensive care unit.

  4. Composite endpoint of persistent organ dysfunction (POD) plus death at day 3 and 7

    Time frame: 3 days and 7 days after surgery

    Persistent organ dysfunction (POD) plus death is a validated outcome measure in cardiac surgery patients. It is defined as one of the following: mechanical ventilation without breaks for a period of more than 48 hours or vasopressor therapy (ongoing need for vasopressor agents such as norepinephrine, epinephrine, vasopressin, dopamine 45 μg/ kg/min, or phenylephrine 450 μg/min for more than 2 hours in a given day); or mechanical circulatory support (ongoing need for mechanical devices such as extracorporeal membrane oxygenation or intra-aortic counterpulsation balloon pump) or continuous renal replacement therapy or new intermittent hemodialysis; or death.

  5. Severe acute kidney injury (KDIGO stage 2 or more) defined by an increase in serum creatinine of ≥200% of baseline.

    Time frame: 7 days after surgery

    The definition of acute kidney injury is based on the KDIGO guidelines

  6. Discontinuous blow flow in renal interlobar vessels

    Time frame: 3 days after surgery

    The presence of abnormal discontinuous blow flow in renal interlobar vessels assessed by bedside Doppler ultrasound.

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • The Montreal Health Innovations Coordinating Center (MHICC)

Registry information

Official study 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

Acronym: PP-AKI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 13, 2016
Registry last updated
Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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