Effect of CVP and IOH on AKI and AKD

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

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

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Acute Kidney Disease
• Intervention / Treatment: Other: Venous congestion; Other: Introperation hypotension

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 5127

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adults undergoing cardiac surgery between 2016 and 2020 (data analysed in 2021) using electronic health records collected from the Nanjing First Hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CVP ≥ 12; central venous pressure ≥12 mmHg	Other: Venous congestion; Venous congestion exposures were quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg
CVP ≥ 16; central venous pressure ≥16 mmHg	Other: Venous congestion; Venous congestion exposures were quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg
CVP ≥ 20; central venous pressure ≥20 mmHg	Other: Venous congestion; Venous congestion exposures were quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg
MAP ≤ 55 mmHg; mean arterial pressure ≤55 mmHg	Other: Introperation hypotension; Introperation hypotension exposures were quantified as area under the curve (AUC) of mean arterial pressure ≤55, 65, 75 mmHg
MAP ≤ 65 mmHg; mean arterial pressure ≤65 mmHg	Other: Introperation hypotension; Introperation hypotension exposures were quantified as area under the curve (AUC) of mean arterial pressure ≤55, 65, 75 mmHg
MAP ≤ 75 mmHg; mean arterial pressure ≤75 mmHg	Other: Introperation hypotension; Introperation hypotension exposures were quantified as area under the curve (AUC) of mean arterial pressure ≤55, 65, 75 mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
RRT initiation	renal replacement theray (RRT) initiation	from the end of operation to the discharge from hospital, up to 90 days.
value of eGFR	postoperative estimated glomerular filtration rate (eGFR), which was calculated by MDRD Equation.	7 days after operation
inpatient mortality	mortality during hospital stay	30 days after inhospital
ICU length of stay	days stay in ICU	from the end of operation to the discharge from ICU, up to 90 days.
length of hospital stay	days stay in hospital	from the end of operation to the discharge from hospital, up to 90 days.

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Principal Investigator: Lihai Chen, PhD, chenlihai1983@163.com

Publications and helpful links

General Publications

• 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.
• 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.
• Weisse AB. Cardiac surgery: a century of progress. Tex Heart Inst J. 2011;38(5):486-90.
• 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.
• Ortega-Loubon C, Fernandez-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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: December 26, 2021
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Intraoperative hypotension; Acute kidney injury; Cardiopulmonary bypass; Acute kidney disease; Central venous pressure
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Acute Kidney Injury
• Other Study ID Numbers: KY20211224-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No