Acute Kidney InjuryNCT06125249
Humanin's Value for Early Diagnosis and Short-term Prognosis in Patients With AKI After Heart Transplantation
An observational study of Acute Kidney Injury and Heart Transplant Surgery, run by Li zhilian at 1 site in China.
Trial summary
The goal of this observational study is to explore the value of Humanin for early diagnosis and short-term prognosis of AKI patients after heart transplantation. The main question it aims to answer are:whether Humanin can be a novel marker for predicting AKI after heart transplantation Researchers will compare the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Heart Transplant Surgery
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart transplant patients from Guangdong Provincial People's Hospital from September 2022 to May 2024
Who may be able to join
- Guangdong Provincial People's Hospital performs heart transplantation；Adult patients ≥ 18 years of age, male or female；Basic renal function is normal before surgery；The patient's baseline medical records are complete, including basic heart diseases, comorbidities, hemoglobin, renal function, urine protein quantification, serum albumin, lactic acid, C-reactive protein, heart transplantation operation time, preoperative and postoperative medication and blood pressure, blood transfusion history, ICU length of stay, cardiac ultrasound (including LVEF), etc；
Who cannot join
- Age< 18 years；Baseline data were missing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangdong, Guangzhou, 510000
zhilian li, Doctor, 13580560903, lizhilian@gdph.org.cn
About this study
The goal of this observational study is to explore the value of Humanin for early diagnosis and short-term prognosis of AKI patients after heart transplantation. The main question it aims to answer are:whether Humanin can be a novel marker for predicting AKI after heart transplantation Researchers will compare the Humanin concentration in patients with AKI did not occur after heart transplantation to see if Humanin can be a novel marker for predicting AKI after heart transplantation
Read the detailed description
Heart transplantation is an important means of treating end-stage heart disease, acute kidney injury is a common complication after heart transplantation, can lead to perioperative and early postoperative patient death, can also lead to the development of chronic kidney disease after heart transplantation, and even progress to ESRD, the literature reports that the incidence of acute kidney injury after heart transplantation is 14% ~ 76%, resulting in severe renal impairment and the proportion requiring dialysis treatment is 5% ~ 39%. The diagnosis of AKI is mainly based on serum creatinine or urine output, and KDIGO criteria are currently used, but it is known that serum creatinine is a very insensitive indicator,so in the past 20 years, scholars have been exploring biological markers that are more sensitive than blood creatinine and urine output. Humanin is a mitochondrial polypeptide containing 24 amino acids. It was first identified in Alzheimer's disease patients in 2001. Studies have shown that Humanin has a strong mitochondrial protective effect in neurodegenerative diseases, cardiovascular diseases, diabetes, male infertility, cancer and other diseases, and its mechanism may be related to anti-apoptosis, anti-inflammation, regulation of autophagy and maintenance of mitochondrial homeostasis, because Humanin can function through autocrine, paracrine or endocrine forms, so it can be detected in the blood. Studies have shown that Humanin expression in serum or plasma of patients with diabetes and coronary heart disease is declined. Our previous study found the concentration of Humanin in AKI patients was significantly higher than in the normal population.
The goal of this observational study is to explore the value of Humanin for early diagnosis and short-term prognosis of AKI patients after heart transplantation.. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI after heart transplantation
- Conditions
- Acute Kidney Injury, Heart Transplant Surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with AKI after heart transplantation | AKI occurs in patients after heart transplantation | |
| Patients did not develop AKI after heart transplantation | Patients who do not develop AKI after heart transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humanin concentration
Highest measured value used
Measured: 3 months
Serum creatinine concentration
Meets KDIGO's definition of AKI
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Jul 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li zhilian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li zhilian, Guangdong Provincial People's Hospital
- Investigators
- zhilian PP li, doctor, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125249
- Sponsor's protocol ID
- KJ012019455
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humanin's Value for Early Diagnosis and Short-term Prognosis in Patients With AKI After Heart Transplantation
- ClinicalTrials.gov ID
- NCT06125249
- Acronym / sponsor ID
- KJ012019455
- Conditions
- Acute Kidney Injury, Heart Transplant Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Li zhilianUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 9 Nov 2023 (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 goal of this observational study is to explore the value of Humanin for early diagnosis and short-term prognosis of AKI patients after heart transplantation. The main question it aims to answer are:whether Humanin can be a novel marker for predicting AKI after heart transplantation Researchers will compare the Humanin concentration in patients with AKI did not occur after heart transplantation to see if Humanin can be a novel marker for predicting AKI after heart transplantation
Detailed description
Heart transplantation is an important means of treating end-stage heart disease, acute kidney injury is a common complication after heart transplantation, can lead to perioperative and early postoperative patient death, can also lead to the development of chronic kidney disease after heart transplantation, and even progress to ESRD, the literature reports that the incidence of acute kidney injury after heart transplantation is 14% ~ 76%, resulting in severe renal impairment and the proportion requiring dialysis treatment is 5% ~ 39%. The diagnosis of AKI is mainly based on serum creatinine or urine output, and KDIGO criteria are currently used, but it is known that serum creatinine is a very insensitive indicator,so in the past 20 years, scholars have been exploring biological markers that are more sensitive than blood creatinine and urine output. Humanin is a mitochondrial polypeptide containing 24 amino acids. It was first identified in Alzheimer's disease patients in 2001. Studies have shown that Humanin has a strong mitochondrial protective effect in neurodegenerative diseases, cardiovascular diseases, diabetes, male infertility, cancer and other diseases, and its mechanism may be related to anti-apoptosis, anti-inflammation, regulation of autophagy and maintenance of mitochondrial homeostasis, because Humanin can function through autocrine, paracrine or endocrine forms, so it can be detected in the blood. Studies have shown that Humanin expression in serum or plasma of patients with diabetes and coronary heart disease is declined. Our previous study found the concentration of Humanin in AKI patients was significantly higher than in the normal population.
The goal of this observational study is to explore the value of Humanin for early diagnosis and short-term prognosis of AKI patients after heart transplantation.. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI after heart transplantation
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with AKI after heart transplantation | – | –AKI occurs in patients after heart transplantation |
| Patients did not develop AKI after heart transplantation | – | –Patients who do not develop AKI after heart transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart transplant patients from Guangdong Provincial People's Hospital from September 2022 to May 2024
Key inclusion criteria (1 listed)
- Guangdong Provincial People's Hospital performs heart transplantation；Adult patients ≥ 18 years of age, male or female；Basic renal function is normal before surgery；The patient's baseline medical records are complete, including basic heart diseases, comorbidities, hemoglobin, renal function, urine protein quantification, serum albumin, lactic acid, C-reactive protein, heart transplantation operation time, preoperative and postoperative medication and blood pressure, blood transfusion history, ICU length of stay, cardiac ultrasound (including LVEF), etc；
Key exclusion criteria (1 listed)
- Age< 18 years；Baseline data were missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Humanin concentration
Time frame: 3 months
Highest measured value used
Serum creatinine concentration
Time frame: 3 months
Meets KDIGO's definition of AKI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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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.
zhilian PP li, doctor principal investigator
Guangdong Provincial People's Hospital
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 and Heart Transplant Surgery, run by Li zhilian 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 1 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 9 Nov 2023. 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 zhilian li, doctor (13580560903, lizhilian@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humanin concentration (time frame: 3 months). 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 9 Nov 2023.