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NCT Number: NCT05222074

Effect of CVP and IOH on AKI and AKD

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

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Key information

Conditions

Acute Kidney Injury Acute Kidney Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venous congestion

Other

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

Introperation hypotension

Other

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. RRT initiation

    Time frame: from the end of operation to the discharge from hospital, up to 90 days.

    renal replacement theray (RRT) initiation

  3. value of eGFR

    Time frame: 7 days after operation

    postoperative estimated glomerular filtration rate (eGFR), which was calculated by MDRD Equation.

  4. inpatient mortality

    Time frame: 30 days after inhospital

    mortality during hospital stay

  5. ICU length of stay

    Time frame: from the end of operation to the discharge from ICU, up to 90 days.

    days stay in ICU

  6. length of hospital stay

    Time frame: from the end of operation to the discharge from hospital, up to 90 days.

    days stay in hospital

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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