Association of Intraoperative Haemodynamic and Postoperative Complications in Type A Aortic Dissection Surgery

NCT06440161 | Completed

• 1 other identifier: KY20230918-KS-02
• Study Type: observational
• Target: 543
• Locations: 1 country
• Sites: 1

Brief Summary

Background To determine whether venous congestion is an important predictor of postoperative kidney injury and other adverse events after type A aortic dissection (TAAD). Methods Authors collected data of adults who underwent surgery for TAAD between January 2016 and July 2023. Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP). The primary outcomes were acute kidney injury (AKI) and acute injury disease (AKD). The secondary outcomes encompassed death and stroke. Restricted cubic spline regression model was used to adjust for confounding factors and multiple comparisons.

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; Intraoperative Hypotension; Venous Congestion; Acute Kidney Disease; Type A Aortic Dissection

Outcome Measures

Primary Outcomes (2)

• The Incidence of AKI

  AKI diagnosis adhered to the Kidney Disease Improvement Global Prognosis Organization (KDIGO) criteria.

  After the surgery，up to 7 days

• The Incidence of AKD

  AKD staging was determined based on the Acute Disease Quality Initiative (ADQI) Working Group consensus, using available Scr values from 8 to 90 days post-surgery.

  After the surgery，longer than 7 days but within 90 days

Secondary Outcomes (5)

• The days of stay in hospital

  perioperatively

• The days of stay in ICU

  after surgery

• The incidence of in-hospital mortality

  after surgery

• The incidence of 30-day all-cause mortality

  after surgery

• The incidence of stroke

  after surgery

Interventions

Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP). OTHER

After the induction of anaesthesia, a central venous or pulmonary artery catheter was positioned. Based on prior studies, thresholds for central venous pressure were set at 10, 12, 16, and 20 mm Hg. Venous congestion was quantified by time exceeding each CVP threshold and the area under the curve (AUC) surpassing each CVP threshold in mmHg × min. Assessments were limited to pre- and post-CPB periods, as the venous drainage cannulate generated negative CVP during CPB. An arterial catheter was installed upon room admission. Continuous arterial blood pressure monitoring commenced after exposure to atmospheric pressure and calibration to zero. The MAP was determined using the formula: 2/3 × diastolic blood pressure + 1/3 × systolic blood pressure. Data were logged by automated software every minute. Established thresholds for MAP were 55, 65, and 75 mm Hg. Hypotension was quantified as (1) time under each MAP threshold in minutes and (2) the AUC below each MAP threshold in mmHg × min.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients underwent surgery for TAAD.

You may qualify if:

• \) Eligible patients were adults, aged 18 or older.

You may not qualify if:

• Lacking preoperative serum creatinine (Scr) values
• Insufficient hemodynamic or laboratory data
• Exhibiting a preoperative Scr level ≥133 μmol/L
• Patients with renal insufficiency before surgery
• Patients on preoperative dialysis

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Acute Kidney Injury; Hyperemia

Interventions

COP protocol 2; Arterial Pressure

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ya-li Ge

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: June 3, 2024
• Study Start: October 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: June 3, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)