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

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ClinicalTrials.gov Identifier: NCT02831907
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
The Montreal Health Innovations Coordinating Center (MHICC)
Information provided by (Responsible Party):
Andre Denault, Montreal Heart Institute

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.

Condition or disease Intervention/treatment
C.Surgical Procedure; Cardiac Acute Kidney Injury Postoperative Complications Right-Sided Heart Failure Cardio-Renal Syndrome Procedure: 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.


Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : August 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing elective or urgent cardiac surgery with the use of cardiopulmonary bypass.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831907


Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
The Montreal Health Innovations Coordinating Center (MHICC)
Investigators
Principal Investigator: André Denault, MD, PhD Montreal Heart Institute

Publications:
Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney inter., Suppl. 2012; 2: 1-138.

Responsible Party: Andre Denault, MD PhD FRCPC ABIM-CCM, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT02831907     History of Changes
Other Study ID Numbers: 2016-1946
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Andre Denault, Montreal Heart Institute:
Ultrasonography
Portal vein Doppler
Renal Doppler
Cardio-Intestinal syndrome
Delirium
Renal congestion
Intra-renal hemodynamics

Additional relevant MeSH terms:
Wounds and Injuries
Heart Failure
Acute Kidney Injury
Postoperative Complications
Cardio-Renal Syndrome
Dextrocardia
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Situs Inversus