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

NCT02831907 | Completed

• 1 other identifier: 2016-1946
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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)

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

  7 days after surgery

Secondary Outcomes (6)

• Mortality

  30 days after surgery

• Duration of intensive care stay

  30 days after surgery

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

  7 days after surgery

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

  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.

  7 days after surgery

Study Arms (1)

Cardiac surgery patients

Adult patients having a cardiac surgery at the Montreal Heart Institute

Procedure: Cardiac surgery

Interventions

Cardiac surgery PROCEDURE

All cardiac surgery procedures with the use of cardiopulmonary bypass

Cardiac surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• The Montreal Health Innovations Coordinating Center (MHICC): collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (11)

• Prowle JR, Echeverri JE, Ligabo EV, Ronco C, Bellomo R. Fluid balance and acute kidney injury. Nat Rev Nephrol. 2010 Feb;6(2):107-15. doi: 10.1038/nrneph.2009.213. Epub 2009 Dec 22.

  PMID: 20027192 BACKGROUND

• McNaughton DA, Abu-Yousef MM. Doppler US of the liver made simple. Radiographics. 2011 Jan-Feb;31(1):161-88. doi: 10.1148/rg.311105093.

  PMID: 21257940 BACKGROUND

• Catalano D, Caruso G, DiFazzio S, Carpinteri G, Scalisi N, Trovato GM. Portal vein pulsatility ratio and heart failure. J Clin Ultrasound. 1998 Jan;26(1):27-31. doi: 10.1002/(sici)1097-0096(199801)26:13.0.co;2-l.

  PMID: 9475205 BACKGROUND

• Bouchard J, Soroko SB, Chertow GM, Himmelfarb J, Ikizler TA, Paganini EP, Mehta RL; Program to Improve Care in Acute Renal Disease (PICARD) Study Group. Fluid accumulation, survival and recovery of kidney function in critically ill patients with acute kidney injury. Kidney Int. 2009 Aug;76(4):422-7. doi: 10.1038/ki.2009.159. Epub 2009 May 13.

  PMID: 19436332 BACKGROUND

• Mullens W, Abrahams Z, Francis GS, Sokos G, Taylor DO, Starling RC, Young JB, Tang WHW. Importance of venous congestion for worsening of renal function in advanced decompensated heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):589-596. doi: 10.1016/j.jacc.2008.05.068.

  PMID: 19215833 BACKGROUND

• Styczynski G, Milewska A, Marczewska M, Sobieraj P, Sobczynska M, Dabrowski M, Kuch-Wocial A, Szmigielski C. Echocardiographic Correlates of Abnormal Liver Tests in Patients with Exacerbation of Chronic Heart Failure. J Am Soc Echocardiogr. 2016 Feb;29(2):132-9. doi: 10.1016/j.echo.2015.09.012. Epub 2015 Nov 6.

  PMID: 26549056 BACKGROUND

• Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11.

  PMID: 27179835 BACKGROUND

• 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.

  BACKGROUND

• Heyland DK, Muscedere J, Drover J, Jiang X, Day AG; Canadian Critical Care Trials Group. Persistent organ dysfunction plus death: a novel, composite outcome measure for critical care trials. Crit Care. 2011;15(2):R98. doi: 10.1186/cc10110. Epub 2011 Mar 18.

  PMID: 21418560 BACKGROUND

• Stoppe C, McDonald B, Benstoem C, Elke G, Meybohm P, Whitlock R, Fremes S, Fowler R, Lamarche Y, Jiang X, Day AG, Heyland DK. Evaluation of Persistent Organ Dysfunction Plus Death As a Novel Composite Outcome in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2016 Jan;30(1):30-8. doi: 10.1053/j.jvca.2015.07.035. Epub 2015 Jul 29.

  PMID: 26847748 BACKGROUND

• Bergeron N, Dubois MJ, Dumont M, Dial S, Skrobik Y. Intensive Care Delirium Screening Checklist: evaluation of a new screening tool. Intensive Care Med. 2001 May;27(5):859-64. doi: 10.1007/s001340100909.

  PMID: 11430542 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Postoperative Complications; Heart Failure; Cardio-Renal Syndrome; Delirium

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• André Denault, MD, PhD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD FRCPC ABIM-CCM

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 13, 2016
• Study Start: August 1, 2016
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)