Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of RRT

NCT03856723 | Unknown DMC

• 1 other identifier: POCKET
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to verify the prognostic value of functional kidney biomarkers on survival and renal function recovery in cardiac surgery patients with acute kidney injury.

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; Renal Replacement Treatment; Biomarker

Outcome Measures

Primary Outcomes (2)

• 28-day mortality

  Death from any cause at 28 days

  28 days

• Dependence on renal-replacement therapy at 28 days in survivors

  Dependence on renal-replacement therapy was defined as surviving dependent on RRT

  28 days

Secondary Outcomes (5)

• 60- and 90-day mortality

  Up to 60 or 90 days

• Length of stay in the ICU

  Up to 90 days or ICU discharge

• Length of stay in the hospital

  Up to 90 days or hospital discharge

• Adverse events

  Up to 90 days

• the number of days free of renal-replacement therapy, mechanical ventilation at 28 days

  28 days

Interventions

Renal Replacement Therapy OTHER

Indications for RRT were defined as previously reported. 1. Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 ; 2. severe sepsis, persistence of hypotension (for more than 6 h) despite preload optimization and use of vasopressors or catecholamines (norepinephrine or epinephrine \>0.1 μg/kg/min), 3. refractory fluid overload (worsening pulmonary edema, PaO2/FiO2 \<300 mm Hg or fluid balance \>10% of body weight), 4. low probability of rapid renal recovery according to the judgment of the intensivists and nephrologists.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%. CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality.

You may qualify if:

• Patients undergoing cardiac surgery who required renal replacement therapy.

You may not qualify if:

• History of End Stage Renal Disease or on Dialysis
• prior kidney transplantation
• patients with a DNR order or "do not escalate care" order

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are drawn before the first dialysis session after post cardiac surgery associated AKI ( initializing RRT). Blood is drawn into Vacutainer tubes containing EDTA, and immediately placed on ice and centrifuged within 1 h. All the samples are stored at -70°C until analysis.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zhe Luo, PhD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Guo-wei Tu, PhD

CONTACT

86-021-64041990; tu.guowei@zs-hospital.sh.cn

Ying Su, MD

CONTACT

86-021-64041990; su.ying@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2019
• First Posted: February 27, 2019
• Study Start: March 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

CN (1)