Effect of CVP and IOH on AKI and AKD

NCT ID: NCT05222074

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2021-08-01

Brief 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

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.

Conditions

Acute Kidney Injury; Acute Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

CVP ≥ 12

central venous pressure ≥12 mmHg

Venous congestion

Intervention Type: OTHER

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

Venous congestion

Intervention Type: OTHER

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

Venous congestion

Intervention Type: OTHER

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

Introperation hypotension

Intervention Type: OTHER

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

Introperation hypotension

Intervention Type: OTHER

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

Introperation hypotension

Intervention Type: OTHER

Introperation hypotension exposures were quantified as area under the curve (AUC) of mean arterial pressure ≤55, 65, 75 mmHg

Interventions

Venous congestion

Venous congestion exposures were quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg

Intervention Type: OTHER

Introperation hypotension

Introperation hypotension exposures were quantified as area under the curve (AUC) of mean arterial pressure ≤55, 65, 75 mmHg

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

HONG LIANG

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lihai Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

chenlihai1983@163.com

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 32771467 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 22163121 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28869251 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27716701 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20338313 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21095340 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21232094 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18667735 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22269723 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18628367 (View on PubMed)

Other Identifiers

KY20211224-09

Identifier Type: -

Identifier Source: org_study_id