Acute Kidney InjuryNCT03856723
Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of RRT
An observational study of Acute Kidney Injury, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Renal Replacement Therapy
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to Dec 2024
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing cardiac surgery who required renal replacement therapy.
Who cannot join
- History of End Stage Renal Disease or on Dialysis
- prior kidney transplantation
- patients with a DNR order or "do not escalate care" order
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital, Fudan university
Shanghai, 200032
Guo-wei Tu, PhD, 86-021-64041990, tu.guowei@zs-hospital.sh.cn
Luo Zhe, PhD, 86-021-64041990, luo.zhe@zs-hospital.sh.cn
About this study
Official title: Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of REnal Replacement Therapy (POCKET)
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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Renal Replacement Therapy
- Keywords
- Acute Kidney Injury, Renal Replacement Treatment, Biomarker
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Replacement TherapyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Death from any cause at 28 days
Measured: 28 days
Dependence on renal-replacement therapy at 28 days in survivors
Dependence on renal-replacement therapy was defined as surviving dependent on RRT
Measured: 28 days
Secondary outcomes (5)
60- and 90-day mortality
Death from any cause at 60- and 90-days
Measured: Up to 60 or 90 days
Length of stay in the ICU
the length of stay in the ICU
Measured: Up to 90 days or ICU discharge
Length of stay in the hospital
the length of stay in the hospital
Measured: Up to 90 days or hospital discharge
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
Measured: Up to 90 days
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Mar 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhe Luo, PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856723
- Sponsor's protocol ID
- Status last verified
- May 2022
- First submitted
- 23 Feb 2019
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of REnal Replacement Therapy (POCKET)
- ClinicalTrials.gov ID
- NCT03856723
- Acronym / sponsor ID
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Renal Replacement Treatment, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery who required renal replacement therapy.
Key exclusion criteria (3 listed)
- History of End Stage Renal Disease or on Dialysis
- prior kidney transplantation
- patients with a DNR order or "do not escalate care" order
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Replacement TherapyIndications 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. | Other | – |
Primary outcome
28-day mortality
Time frame: 28 days
Death from any cause at 28 days
Dependence on renal-replacement therapy at 28 days in survivors
Time frame: 28 days
Dependence on renal-replacement therapy was defined as surviving dependent on RRT
5 secondary outcomes
60- and 90-day mortality
Time frame: Up to 60 or 90 days
Length of stay in the ICU
Time frame: Up to 90 days or ICU discharge
Length of stay in the hospital
Time frame: Up to 90 days or hospital discharge
Adverse events
Time frame: Up to 90 days
the number of days free of renal-replacement therapy, mechanical ventilation at 28 days
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhe Luo, PhD study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guo-wei Tu, PhD (86-021-64041990, tu.guowei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.