Clinical trial NCT05222074: Effect of CVP and IOH on AKI and AKD
Official title: Venous Congestion Rather Than Intraoperative Hypotension is Associated With Acute Adverse Kidney Events After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Acute Kidney Disease
Keywords: Acute kidney injury
Intraoperative hypotension
Central venous pressure
Acute kidney disease
Cardiopulmonary bypass
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 5127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: CSA-AKI
timeFrame: 7 days post operation
measure: AKD
timeFrame: 8 to 90 days post operation
Secondary outcomes:
measure: Incidence of AKD of stage 2 and above
timeFrame: 8 to 90 days post operation
measure: RRT initiation
timeFrame: from the end of operation to the discharge from hospital, up to 90 days.
measure: value of eGFR
timeFrame: 7 days after operation
measure: inpatient mortality
timeFrame: 30 days after inhospital
measure: ICU length of stay
timeFrame: from the end of operation to the discharge from ICU, up to 90 days.
measure: length of hospital stay
timeFrame: from the end of operation to the discharge from hospital, up to 90 days.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: chenlihai1983@163.com
name: Lihai Chen, PhD
role: PRINCIPAL_INVESTIGATOR
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