Acute Kidney Injury Due to SepsisNCT04633746
Plasma Endostatin Predicts Outcome of Septic AKI
An observational study of Acute Kidney Injury Due to Sepsis, run by Cairo University at 1 site in Egypt.
Trial summary
Introduction: Acute kidney injury (AKI) occurs up to 50% of patients admitted to intensive care unit. Plasma Endostatin, released from basement membrane of Bowman's capsule, rises early during AKI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury Due to Sepsis
- What is being tested?
- measuring plasma Endostatin level
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2019to 31 Aug 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age: 18- 80 years . - No gender preference
Who may be able to join
- Patients with sepsis defined According to Surviving Sepsis Campaign 2016 sepsis: Suspected or documented infection in addition to increase in SOFA score 2 points or more from the baseline108.
- The patients will be followed for development of acute kidney injury (AKI) defined according to criteria established by Kidney Disease Improving Global Outcome guidelines (KDIGO) 20129 which includes any of the following criteria:
- Increase in serum creatinine by > 0.3 mg/dl within 48 hours; or
- Increase in serum creatinine to > 1.5 times baseline, which is Known or presumed to have occurred within the prior 7 days; or
- Urine volume < 0.5 ml/kg/h for 6 hours.
Who cannot join
- Critically ill patients with known history of CKD.
- Patients on RRT ( intermittent or continuous)
- Post renal AKI.
- Not known history of nephrotoxic drug intake.
- Patient with contrast induced nephropathy
- Patients with cardiogenic shock who developed AKI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Plasma Endostatin for Predicting Renal Outcome From Acute Kidney Injury Induced by Sepsis
Introduction: Acute kidney injury (AKI) occurs up to 50% of patients admitted to intensive care unit. Plasma Endostatin, released from basement membrane of Bowman's capsule, rises early during AKI.
Aim of Work: To investigate the role of the plasma endostatin in the outcome prediction (renal recovery, ICU stay, mortality) of acute kidney injury in patients with sepsis.
Methods: a prospective, observational single center study on 40 patients with Sepsis at the Critical Care Department, Cairo University hospitals between March 2019 and November 2019. Serum plasma endostatin was measured at the day of admission \& every 48hrs (3 samples). APACHE II, SOFA scores were calculated. Forced diuresis was used if indicated.
Read the detailed description
The study was conducted on 40 patients with sepsis who admitted in the Critical Care department of Cairo University.
The sepsis is identified according to surviving sepsis campaign guidelines with use of SOFA score to establish the diagnosis.
The patients divided into 2 groups the first group included 25 patients who developed AKI as defined by KDIGO guidelines and the other group included 15 patients as a control group.
The Plasma Endostatin level is sampled in the first 24 hours of diagnosis of AKI, the estimation of plasma Endostatin level done by ELISA technique.
The results were presented in form of: descriptive, analytical and comparative data between the groups of study.
It was found that the patients with higher levels of plasma endostatin had a higher incidence of recovery from AKI and higher incidence of 28 days survival, while the patients with lower levels of plasma Endostatin below the determined Cut-off value have increased incidence of RRT .
Also that the patients with higher levels of plasma Endostatin levels were less labile to mechanical ventilation and had a higher incidence of weaning of vasopressors in comparison of the other group of lower levels of plasma Endostatin.
Plasma Endostatin levels have no difference between the AKI group and sepsis group which may need further investigations to determine its role in sepsis.
so that, the plasma Endostatin can be used as a marker of recovery from AKI.
- Conditions
- Acute Kidney Injury Due to Sepsis
- Being tested
- measuring plasma Endostatin level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring plasma Endostatin levelDiagnostic test
measuring plasma Endostatin level at the time of admission then after 48hrs and 96 hours
| Study group | Role | What they receive |
|---|---|---|
| sepsis with AKI | Patients admitted with the diagnosis of sepsis associated with elevation of renal function tests Receives: Diagnostic Test: measuring plasma Endostatin level | |
| Sepsis without AKI | Patients admitted with the diagnosis of sepsis with no elevation of renal function tests Receives: Diagnostic Test: measuring plasma Endostatin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal outcme
Number of participants who have recovered renal functions \& those who needed Renal replacement therapy
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start20 Jan 2019
- Primary completion30 Jun 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury Due to SepsisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Farouk, Cairo University
- Investigators
- farouk faris, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633746
- Sponsor's protocol ID
- I-801016
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Plasma Endostatin for Predicting Renal Outcome From Acute Kidney Injury Induced by Sepsis
- ClinicalTrials.gov ID
- NCT04633746
- Acronym / sponsor ID
- I-801016
- Conditions
- Acute Kidney Injury Due to Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 18 Nov 2020 (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.
Introduction: Acute kidney injury (AKI) occurs up to 50% of patients admitted to intensive care unit. Plasma Endostatin, released from basement membrane of Bowman's capsule, rises early during AKI.
Aim of Work: To investigate the role of the plasma endostatin in the outcome prediction (renal recovery, ICU stay, mortality) of acute kidney injury in patients with sepsis.
Methods: a prospective, observational single center study on 40 patients with Sepsis at the Critical Care Department, Cairo University hospitals between March 2019 and November 2019. Serum plasma endostatin was measured at the day of admission \& every 48hrs (3 samples). APACHE II, SOFA scores were calculated. Forced diuresis was used if indicated.
Detailed description
The study was conducted on 40 patients with sepsis who admitted in the Critical Care department of Cairo University.
The sepsis is identified according to surviving sepsis campaign guidelines with use of SOFA score to establish the diagnosis.
The patients divided into 2 groups the first group included 25 patients who developed AKI as defined by KDIGO guidelines and the other group included 15 patients as a control group.
The Plasma Endostatin level is sampled in the first 24 hours of diagnosis of AKI, the estimation of plasma Endostatin level done by ELISA technique.
The results were presented in form of: descriptive, analytical and comparative data between the groups of study.
It was found that the patients with higher levels of plasma endostatin had a higher incidence of recovery from AKI and higher incidence of 28 days survival, while the patients with lower levels of plasma Endostatin below the determined Cut-off value have increased incidence of RRT .
Also that the patients with higher levels of plasma Endostatin levels were less labile to mechanical ventilation and had a higher incidence of weaning of vasopressors in comparison of the other group of lower levels of plasma Endostatin.
Plasma Endostatin levels have no difference between the AKI group and sepsis group which may need further investigations to determine its role in sepsis.
so that, the plasma Endostatin can be used as a marker of recovery from AKI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sepsis with AKI | – | Diagnostic Test: measuring plasma Endostatin levelPatients admitted with the diagnosis of sepsis associated with elevation of renal function tests |
| Sepsis without AKI | – | Diagnostic Test: measuring plasma Endostatin levelPatients admitted with the diagnosis of sepsis with no elevation of renal function tests |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age: 18- 80 years . - No gender preference
Key inclusion criteria (5 listed)
- Patients with sepsis defined According to Surviving Sepsis Campaign 2016 sepsis: Suspected or documented infection in addition to increase in SOFA score 2 points or more from the baseline108.
- The patients will be followed for development of acute kidney injury (AKI) defined according to criteria established by Kidney Disease Improving Global Outcome guidelines (KDIGO) 20129 which includes any of the following criteria:
Key exclusion criteria (6 listed)
- Critically ill patients with known history of CKD.
- Patients on RRT ( intermittent or continuous)
- Post renal AKI.
- Not known history of nephrotoxic drug intake.
- Patient with contrast induced nephropathy
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 |
|---|---|---|
| measuring plasma Endostatin levelmeasuring plasma Endostatin level at the time of admission then after 48hrs and 96 hours | Diagnostic test | Sepsis without AKI, sepsis with AKI |
Primary outcome
Renal outcme
Time frame: 7 days
Number of participants who have recovered renal functions \& those who needed Renal replacement therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: No
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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.
farouk faris principal investigator
Cairo 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 Due to Sepsis, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 18 Nov 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal outcme (time frame: 7 days). 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 18 Nov 2020.