Effect of CVP and IOH on AKI and AKD

Acute Kidney Injury Clinical Trial

Official title:

Venous Congestion Rather Than Intraoperative Hypotension is Associated With Acute Adverse Kidney Events After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222074
• Other study ID #: KY20211224-09
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: August 1, 2021

Study information

• Verified date: January 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study was aimed to explore the effect of intraoperative venous congestion and intraoperative hypotension (IOH) on acute adverse kidney events, defined as acute kidney injury (AKI) and acute kidney disease (AKD), after cardiac surgery

Description:

Venous congestion and IOH were primary exposures and quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg or mean arterial pressure ≤55, 65, 75 mmHg. The primary outcome was AKI or AKD defined as renal dysfunction persisting > 7 days after surgery. Multivariable logistic regression and Cox proportional hazard models were used to determine the association between intraoperative venous congestion/hypotension and postoperative acute adverse kidney events, respectively, adjusted for relevant confounding factors and multiple comparisons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5127
• Est. completion date: August 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients aged 18 years and older,

• Patients underwent cardiac surgery (coronary artery bypass grafting, heart valve surgery, heart transplant or surgical excision of intracardiac myxoma)

• Patients receiving invasive intraoperative BP monitoring during surgery

• Patients underwent cardiopulmonary bypass (CPB) during surgery

Exclusion Criteria:

• Pre-existing renal insufficiency defined by presence of abnormal preoperative serum creatinine = 133 µmol/L and/or preoperative diagnosis of renal insufficiency within 6 months'preoperative period.

• Patients with preoperative dialysis dependence within 60 days before the index surgical procedure,

• Surgical duration less than 30 minutes

• Surgery on the aorta

• Insufficient hemodynamic and laboratory data for outcomes and/or exposure ascertainment

Related Conditions & MeSH terms

• Acute Kidney Disease
• Acute Kidney Injury
• Kidney Diseases

Intervention

Other:
• Venous congestion
Venous congestion exposures were quantified as area under the curve (AUC) of central venous pressure =12, 16 or 20 mmHg
• Introperation hypotension
Introperation hypotension exposures were quantified as area under the curve (AUC) of mean arterial pressure =55, 65, 75 mmHg

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (10)

Arora P, Rajagopalam S, Ranjan R, Kolli H, Singh M, Venuto R, Lohr J. Preoperative use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers is associated with increased risk for acute kidney injury after cardiovascular surgery. Clin J Am Soc Nephrol. 2008 Sep;3(5):1266-73. doi: 10.2215/CJN.05271107. Epub 2008 Jul 30. — View Citation

Englberger L, Suri RM, Li Z, Casey ET, Daly RC, Dearani JA, Schaff HV. Clinical accuracy of RIFLE and Acute Kidney Injury Network (AKIN) criteria for acute kidney injury in patients undergoing cardiac surgery. Crit Care. 2011;15(1):R16. doi: 10.1186/cc9960. Epub 2011 Jan 13. — View Citation

Ortega-Loubon C, Fernández-Molina M, Carrascal-Hinojal Y, Fulquet-Carreras E. Cardiac surgery-associated acute kidney injury. Ann Card Anaesth. 2016 Oct-Dec;19(4):687-698. doi: 10.4103/0971-9784.191578. Review. — View Citation

Ouzounian M, Buth KJ, Valeeva L, Morton CC, Hassan A, Ali IS. Impact of preoperative angiotensin-converting enzyme inhibitor use on clinical outcomes after cardiac surgery. Ann Thorac Surg. 2012 Feb;93(2):559-64. doi: 10.1016/j.athoracsur.2011.10.058. — View Citation

Robert AM, Kramer RS, Dacey LJ, Charlesworth DC, Leavitt BJ, Helm RE, Hernandez F, Sardella GL, Frumiento C, Likosky DS, Brown JR; Northern New England Cardiovascular Disease Study Group. Cardiac surgery-associated acute kidney injury: a comparison of two consensus criteria. Ann Thorac Surg. 2010 Dec;90(6):1939-43. doi: 10.1016/j.athoracsur.2010.08.018. — View Citation

Swaminathan M, Hudson CC, Phillips-Bute BG, Patel UD, Mathew JP, Newman MF, Milano CA, Shaw AD, Stafford-Smith M. Impact of early renal recovery on survival after cardiac surgery-associated acute kidney injury. Ann Thorac Surg. 2010 Apr;89(4):1098-104. doi: 10.1016/j.athoracsur.2009.12.018. — View Citation

Vervoort D, Swain JD, Pezzella AT, Kpodonu J. Cardiac Surgery in Low- and Middle-Income Countries: A State-of-the-Art Review. Ann Thorac Surg. 2021 Apr;111(4):1394-1400. doi: 10.1016/j.athoracsur.2020.05.181. Epub 2020 Aug 6. Review. — View Citation

Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4. Review. — View Citation

Weisse AB. Cardiac surgery: a century of progress. Tex Heart Inst J. 2011;38(5):486-90. — View Citation

Welten GM, Chonchol M, Schouten O, Hoeks S, Bax JJ, van Domburg RT, van Sambeek M, Poldermans D. Statin use is associated with early recovery of kidney injury after vascular surgery and improved long-term outcome. Nephrol Dial Transplant. 2008 Dec;23(12):3867-73. doi: 10.1093/ndt/gfn381. Epub 2008 Jul 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSA-AKI	Cardiovascular surgery associated acute kidney injury. AKI was defined using the Kidney Disease: Improving Global Outcome (KDIGO) Clinical Practice Guideline for Acute Kidney Injury as an absolute increase in serum creatinine of = 26 µmol/L within 48 hours or an increase in serum creatinine beyond 1.5 times the baseline value within 7 days	7 days post operation
Primary	AKD	Acute Kidney Disease, which was defined according to the criteria recommended by the Acute Disease Quality Initiative (ADQI) workgroup.4 AKI was quantified within the 7 days' postoperative period, while AKD was defined as serum creatinine value elevated to 1.5 times the baseline value between 8- and 90-day post-operation period.	8 to 90 days post operation
Secondary	Incidence of AKD of stage 2 and above	incidence of AKD of stage 2 and above, defined as increase in serum creatinine beyond 2.0 times the baseline value between 8- and 90-day post-operation period.	8 to 90 days post operation
Secondary	RRT initiation	renal replacement theray (RRT) initiation	from the end of operation to the discharge from hospital, up to 90 days.
Secondary	value of eGFR	postoperative estimated glomerular filtration rate (eGFR), which was calculated by MDRD Equation.	7 days after operation
Secondary	inpatient mortality	mortality during hospital stay	30 days after inhospital
Secondary	ICU length of stay	days stay in ICU	from the end of operation to the discharge from ICU, up to 90 days.
Secondary	length of hospital stay	days stay in hospital	from the end of operation to the discharge from hospital, up to 90 days.