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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03856723
• Other study ID #: POCKET
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: May 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Guo-wei Tu, PhD
• Phone: 86-021-64041990
• Email: tu.guowei[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• Renal Replacement Therapy
Indications for RRT were defined as previously reported. Kidney Disease: Improving Global Outcomes (KDIGO) stage 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), refractory fluid overload (worsening pulmonary edema, PaO2/FiO2 <300 mm Hg or fluid balance >10% of body weight), low probability of rapid renal recovery according to the judgment of the intensivists and nephrologists.

Locations

Country	Name	City	State
China	Zhongshan hospital, Fudan university	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	Death from any cause at 28 days	28 days
Primary	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	60- and 90-day mortality	Death from any cause at 60- and 90-days	Up to 60 or 90 days
Secondary	Length of stay in the ICU	the length of stay in the ICU	Up to 90 days or ICU discharge
Secondary	Length of stay in the hospital	the length of stay in the hospital	Up to 90 days or hospital discharge
Secondary	Adverse events	with a focus on the complications potentially related to acute kidney injury or renal-replacement therapy during the first 7 days after enrollment	Up to 90 days
Secondary	the number of days free of renal-replacement therapy, mechanical ventilation at 28 days	the number of days free of renal-replacement therapy, mechanical ventilation at 28 days	28 days