Portal Flow Pulsatility as a Risk Factor for Acute Kidney Injury After Cardiac Surgery (PP-AKI)

August 28, 2017 updated by: Andre Denault, Montreal Heart Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing elective or urgent cardiac surgery with the use of cardiopulmonary bypass.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac surgery patients
Adult patients having a cardiac surgery at the Montreal Heart Institute
Procedure: Cardiac surgery
All cardiac surgery procedures with the use of cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days after surgery
30 days after surgery
Duration of intensive care stay
Time Frame: 30 days after surgery
30 days after surgery
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.
7 days after surgery
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.
3 days and 7 days after surgery
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
7 days after surgery
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.
3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Collaborators

The Montreal Health Innovations Coordinating Center (MHICC)

Investigators

  • Principal Investigator: André Denault, MD, PhD, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

July 31, 2017

Study Completion (ACTUAL)

July 31, 2017

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (ESTIMATE)

July 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-1946

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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