Effect of CVP and IOH on AKI and AKD

January 23, 2022 updated by: HONG LIANG, Nanjing First Hospital, Nanjing Medical University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CVP ≥ 12
central venous pressure ≥12 mmHg
Other: Venous congestion
Venous congestion exposures were quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg
CVP ≥ 16
central venous pressure ≥16 mmHg
Other: Venous congestion
Venous congestion exposures were quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg
CVP ≥ 20
central venous pressure ≥20 mmHg
Other: Venous congestion
Venous congestion exposures were quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg
MAP ≤ 55 mmHg
mean arterial pressure ≤55 mmHg
Other: Introperation hypotension
Introperation hypotension exposures were quantified as area under the curve (AUC) of mean arterial pressure ≤55, 65, 75 mmHg
MAP ≤ 65 mmHg
mean arterial pressure ≤65 mmHg
Other: Introperation hypotension
Introperation hypotension exposures were quantified as area under the curve (AUC) of mean arterial pressure ≤55, 65, 75 mmHg
MAP ≤ 75 mmHg
mean arterial pressure ≤75 mmHg
Other: Introperation hypotension
Introperation hypotension exposures were quantified as area under the curve (AUC) of mean arterial pressure ≤55, 65, 75 mmHg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CSA-AKI
Time Frame: 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
7 days post operation
AKD
Time Frame: 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.
8 to 90 days post operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of AKD of stage 2 and above
Time Frame: 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.
8 to 90 days post operation
RRT initiation
Time Frame: from the end of operation to the discharge from hospital, up to 90 days.
renal replacement theray (RRT) initiation
from the end of operation to the discharge from hospital, up to 90 days.
value of eGFR
Time Frame: 7 days after operation
postoperative estimated glomerular filtration rate (eGFR), which was calculated by MDRD Equation.
7 days after operation
inpatient mortality
Time Frame: 30 days after inhospital
mortality during hospital stay
30 days after inhospital
ICU length of stay
Time Frame: from the end of operation to the discharge from ICU, up to 90 days.
days stay in ICU
from the end of operation to the discharge from ICU, up to 90 days.
length of hospital stay
Time Frame: from the end of operation to the discharge from hospital, up to 90 days.
days stay in hospital
from the end of operation to the discharge from hospital, up to 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing First Hospital, Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lihai Chen, PhD, chenlihai1983@163.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20211224-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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