Effect of CVP and IOH on AKI and AKD

N/ACompletedNCT05222074

Nanjing First Hospital, Nanjing Medical University5,127 enrolled

Overview

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

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

5,127

Conditions

Acute Kidney Injury Acute Kidney Disease

Interventions

Venous congestionOTHER

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

Introperation hypotensionOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 8 to 90 days post operation

Secondary Outcomes

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.

Time frame: 8 to 90 days post operation

RRT initiation

renal replacement theray (RRT) initiation

Time frame: 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.

Time frame: 7 days after operation

inpatient mortality

mortality during hospital stay

Time frame: 30 days after inhospital

ICU length of stay

Data from ClinicalTrials.gov

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