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

Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of REnal Replacement Therapy (POCKET)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03856723
Enrollment
1200
Registered
2019-02-27
Start date
2019-03-01
Completion date
2024-12-31
Last updated
2022-06-01

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

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury, Renal Replacement Treatment, Biomarker

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.

Detailed description

Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. Few biomarkers were validated as outcome-specific biomarkers in patients developing AKI after cardiac surgery at initiation of RRT. This study was designed to not only verify the prognostic value of functional kidney biomarkers on survival, but also predict it severity in order to optimize clinical decision making with respect to dialysis initiation and discontinuation.

Interventions

OTHERRenal Replacement Therapy

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.

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* Patients undergoing cardiac surgery who required renal replacement therapy.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
28-day mortality28 daysDeath from any cause at 28 days
Dependence on renal-replacement therapy at 28 days in survivors28 daysDependence on renal-replacement therapy was defined as surviving dependent on RRT

Secondary

MeasureTime frameDescription
Length of stay in the hospitalUp to 90 days or hospital dischargethe length of stay in the hospital
60- and 90-day mortalityUp to 60 or 90 daysDeath from any cause at 60- and 90-days
the number of days free of renal-replacement therapy, mechanical ventilation at 28 days28 daysthe number of days free of renal-replacement therapy, mechanical ventilation at 28 days
Adverse eventsUp to 90 dayswith a focus on the complications potentially related to acute kidney injury or renal-replacement therapy during the first 7 days after enrollment
Length of stay in the ICUUp to 90 days or ICU dischargethe length of stay in the ICU

Countries

China

Contacts

Primary ContactGuo-wei Tu, PhD
tu.guowei@zs-hospital.sh.cn86-021-64041990
Backup ContactYing Su, MD
su.ying@zs-hospital.sh.cn86-021-64041990

Outcome results

None listed

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