Effect of CVP and IOH on AKI and AKD

NCT05222074 | Completed

• 1 other identifier: KY20211224-09
• Study Type: observational
• Target: 5,127
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Kidney Injury; Acute Kidney Disease

Keywords

Acute kidney injury; Intraoperative hypotension; Central venous pressure; Acute kidney disease; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Incidence of AKD of stage 2 and above

  8 to 90 days post operation

• RRT initiation

  from the end of operation to the discharge from hospital, up to 90 days.

• value of eGFR

  7 days after operation

• inpatient mortality

  30 days after inhospital

• ICU length of stay

  from the end of operation to the discharge from ICU, up to 90 days.

Study Arms (6)

CVP ≥ 12

central venous pressure ≥12 mmHg

Other: Venous congestion

CVP ≥ 16

central venous pressure ≥16 mmHg

Other: Venous congestion

CVP ≥ 20

central venous pressure ≥20 mmHg

Other: Venous congestion

MAP ≤ 55 mmHg

mean arterial pressure ≤55 mmHg

Other: Introperation hypotension

MAP ≤ 65 mmHg

mean arterial pressure ≤65 mmHg

Other: Introperation hypotension

MAP ≤ 75 mmHg

mean arterial pressure ≤75 mmHg

Other: Introperation hypotension

Interventions

Venous congestion OTHER

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

CVP ≥ 12; CVP ≥ 16; CVP ≥ 20

Introperation hypotension OTHER

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

MAP ≤ 55 mmHg; MAP ≤ 65 mmHg; MAP ≤ 75 mmHg

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (10)

• 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.

  PMID: 32771467 BACKGROUND

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

  PMID: 22163121 BACKGROUND

• 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.

  PMID: 28869251 BACKGROUND

• 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.

  PMID: 27716701 BACKGROUND

• 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.

  PMID: 20338313 BACKGROUND

• 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.

  PMID: 21095340 BACKGROUND

• 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.

  PMID: 21232094 BACKGROUND

• 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.

  PMID: 18667735 BACKGROUND

• 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.

  PMID: 22269723 BACKGROUND

• 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.

  PMID: 18628367 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lihai Chen, PhD

  chenlihai1983@163.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: February 3, 2022
• Study Start: June 1, 2016
• Primary Completion: June 30, 2021
• Study Completion: August 1, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)