Effect of CVP and IOH on AKI and AKD

Completed

• Conditions: Acute Kidney Injury; Acute Kidney Disease
• Interventions: Other: Introperation hypotension; Other: Venous congestion

• Registration Number: NCT05222074
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-01
• Study First Submitted: 2021-12-26
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-23
• Last Update Submitted: 2022-01-23
• Study First Posted: 2022-02-03
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5127

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MAP ≤ 65 mmHg	Introperation hypotension	mean arterial pressure ≤65 mmHg
CVP ≥ 16	Venous congestion	central venous pressure ≥16 mmHg
CVP ≥ 12	Venous congestion	central venous pressure ≥12 mmHg
MAP ≤ 75 mmHg	Introperation hypotension	mean arterial pressure ≤75 mmHg
CVP ≥ 20	Venous congestion	central venous pressure ≥20 mmHg
MAP ≤ 55 mmHg	Introperation hypotension	mean arterial pressure ≤55 mmHg

Primary Outcome Measures

Name	Time	Method
AKD	8 to 90 days post operation	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.
CSA-AKI	7 days post operation	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

Secondary Outcome Measures

Name	Time	Method
inpatient mortality	30 days after inhospital	mortality during hospital stay
Incidence of AKD of stage 2 and above	8 to 90 days post operation	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.
length of hospital stay	from the end of operation to the discharge from hospital, up to 90 days.	days stay in hospital
RRT initiation	from the end of operation to the discharge from hospital, up to 90 days.	renal replacement theray (RRT) initiation
value of eGFR	7 days after operation	postoperative estimated glomerular filtration rate (eGFR), which was calculated by MDRD Equation.
ICU length of stay	from the end of operation to the discharge from ICU, up to 90 days.	days stay in ICU

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China