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Effect of CVP and IOH on AKI and AKD

Venous Congestion Rather Than Intraoperative Hypotension is Associated With Acute Adverse Kidney Events After Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05222074
Enrollment
5127
Registered
2022-02-03
Start date
2016-06-01
Completion date
2021-08-01
Last updated
2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Disease, Acute Kidney Injury

Keywords

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

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.

Interventions

OTHERVenous congestion

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

OTHERIntroperation hypotension

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

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CSA-AKI7 days post operationCardiovascular 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
AKD8 to 90 days post operationAcute 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.

Secondary

MeasureTime frameDescription
value of eGFR7 days after operationpostoperative estimated glomerular filtration rate (eGFR), which was calculated by MDRD Equation.
inpatient mortality30 days after inhospitalmortality during hospital stay
Incidence of AKD of stage 2 and above8 to 90 days post operationincidence 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 stayfrom the end of operation to the discharge from hospital, up to 90 days.days stay in hospital
ICU length of stayfrom the end of operation to the discharge from ICU, up to 90 days.days stay in ICU
RRT initiationfrom the end of operation to the discharge from hospital, up to 90 days.renal replacement theray (RRT) initiation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026