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

NCT ID: NCT03856723

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Renal 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhe Luo, PhD

Role: STUDY_CHAIR

Fudan University

Locations

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Zhongshan hospital, Fudan university

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guo-wei Tu, PhD

Role: CONTACT

86-021-64041990

Ying Su, MD

Role: CONTACT

86-021-64041990

Facility Contacts

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Guo-wei Tu, PhD

Role: primary

86-021-64041990

Luo Zhe, PhD

Role: backup

86-021-64041990

Other Identifiers

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POCKET

Identifier Type: -

Identifier Source: org_study_id

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