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

Acute Kidney Injury Clinical Trial

— PP-AKI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831907
• Other study ID #: 2016-1946
• Status: Completed
• Phase: N/A
• First received: July 5, 2016
• Last updated: August 28, 2017
• Start date: August 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2017
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• C.Surgical Procedure; Cardiac
• Cardio-Renal Syndrome
• Heart Failure
• Postoperative Complications
• Right-Sided Heart Failure
• Wounds and Injuries

Intervention

Procedure:
• Cardiac surgery
All cardiac surgery procedures with the use of cardiopulmonary bypass

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	The Montreal Health Innovations Coordinating Center (MHICC)

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. Review. Erratum in: Radiographics. 2011 May-Jun;31(3):904. — View Citation

Mullens W, Abrahams Z, Francis GS, Sokos G, Taylor DO, Starling RC, Young JB, Tang WH. Importance of venous congestion for worsening of renal function in advanced decompensated heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):589-96. doi: 10.1016/j.jacc.2008.05.068. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality		30 days after surgery
Secondary	Duration of intensive care stay		30 days after surgery
Secondary	Delirium defined as an Intensive Care Delirium Screening Checklist score of 4 or more.	Intensive Care Delirium Screening Checklist is a validated tool for the screening of delirium in the intensive care unit.	7 days after surgery
Secondary	Composite endpoint of persistent organ dysfunction (POD) plus death at day 3 and 7	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
Secondary	Severe acute kidney injury (KDIGO stage 2 or more) defined by an increase in serum creatinine of =200% of baseline.	The definition of acute kidney injury is based on the KDIGO guidelines	7 days after surgery
Secondary	Discontinuous blow flow in renal interlobar vessels	The presence of abnormal discontinuous blow flow in renal interlobar vessels assessed by bedside Doppler ultrasound.	3 days after surgery