Acute Kidney InjuryNCT06090773
Characteristics of Renal Blood Flow in AKI Patients in ICU and Its Clinical Significance
An observational study of Acute Kidney Injury and Renal Artery Blood Flow, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To study the changes in the renal artery and renal vein with renal cortical and medullary microcirculatory blood flow in patients with sepsis; to study the relationship between renal arteriolar and renal vein with renal cortical and medullary microcirculatory blood flow and renal function; and to find the value of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury, Renal Artery Blood Flow, Renal Venous Return
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Dec 2023
- 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 85 years
- All sexes
- Adult, Older adult
Study population: Age between 18-85 years old; Control group: patients with non-acute kidney injury after ICU general surgery; Observation group: patients who met the diagnostic criteria of AKI: Scr elevation ≥26.5 umol/L within 48h; Scr elevation exceeding 1.5 times and more than the basal value within 7d; and decrease in urine output (<0.5 ml/kg/h) with a duration of 6h or more.
Who may be able to join
- Age between 18-85 years old; Control group: patients with non-acute kidney injury after ICU general surgery; Observation group: patients who met the diagnostic criteria of AKI: Scr elevation ≥26.5 umol/L within 48h; Scr elevation exceeding 1.5 times and more than the basal value within 7d; and decrease in urine output (<0.5 ml/kg/h) with a duration of 6h or more.
Who cannot join
- Those who did not meet the inclusion criteria or refused to be enrolled; patients with underlying end-stage renal disease or requiring long-term dialysis; renal transplant patients; patients with other underlying systemic diseases causing renal dysfunction (SCr > 88.4 umol/L); those who were unable to obtain a clear renal ultrasound view; those with suspected contrast allergy; those with pulmonary arterial systolic blood pressure ≥ 90 mm Hg; and those who were pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Renal Blood Flow in AKI Patients With Sepsis and Its Clinical Significance
To study the changes in the renal artery and renal vein with renal cortical and medullary microcirculatory blood flow in patients with sepsis; to study the relationship between renal arteriolar and renal vein with renal cortical and medullary microcirculatory blood flow and renal function; and to find the value of ultrasonographic assessment of renal blood flow indices for evaluating prognosis in patients with sepsis.
- 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 |
|---|---|---|
| Acute kidney injury | Patients with acute injuries in ICU patients. | |
| Patients with non-acute kidney injury | ICU patients without acute injury patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day major renal adverse events
Follow-up of patients with prognostic indicators of renal function within 30 days of enrolment, such as blood creatinine and the need for renal replacement therapy.
Measured: 30-day
Renal artery blood flow
Ultrasound assessment of renal artery resistance index, and renal artery blood flow.
Measured: Day 1,Day 3,Day 5, Day 7
Renal venous return
Ultrasonographic assessment of renal venous reflux profiles.
Measured: Day 1,Day 3,Day 5, Day 7
renal microcirculation
Evaluation of renal microcirculation by ultrasonography.
Measured: Day 1,Day 3,Day 5, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion30 Dec 2023
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 Peking Union Medical College 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090773
- Sponsor's protocol ID
- 2022-PUMCH-A-218
- Status last verified
- Feb 2024
- First submitted
- 14 Oct 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Renal Blood Flow in AKI Patients With Sepsis and Its Clinical Significance
- ClinicalTrials.gov ID
- NCT06090773
- Acronym / sponsor ID
- 2022-PUMCH-A-218
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 19 Oct 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.
To study the changes in the renal artery and renal vein with renal cortical and medullary microcirculatory blood flow in patients with sepsis; to study the relationship between renal arteriolar and renal vein with renal cortical and medullary microcirculatory blood flow and renal function; and to find the value of ultrasonographic assessment of renal blood flow indices for evaluating prognosis in patients with sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute kidney injury | – | –Patients with acute injuries in ICU patients. |
| Patients with non-acute kidney injury | – | –ICU patients without acute injury patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Age between 18-85 years old; Control group: patients with non-acute kidney injury after ICU general surgery; Observation group: patients who met the diagnostic criteria of AKI: Scr elevation ≥26.5 umol/L within 48h; Scr elevation exceeding 1.5 times and more than the basal value within 7d; and decrease in urine output (<0.5 ml/kg/h) with a duration of 6h or more.
Key inclusion criteria (1 listed)
- Age between 18-85 years old; Control group: patients with non-acute kidney injury after ICU general surgery; Observation group: patients who met the diagnostic criteria of AKI: Scr elevation ≥26.5 umol/L within 48h; Scr elevation exceeding 1.5 times and more than the basal value within 7d; and decrease in urine output (<0.5 ml/kg/h) with a duration of 6h or more.
Key exclusion criteria (1 listed)
- Those who did not meet the inclusion criteria or refused to be enrolled; patients with underlying end-stage renal disease or requiring long-term dialysis; renal transplant patients; patients with other underlying systemic diseases causing renal dysfunction (SCr > 88.4 umol/L); those who were unable to obtain a clear renal ultrasound view; those with suspected contrast allergy; those with pulmonary arterial systolic blood pressure ≥ 90 mm Hg; and those who were pregnant or breastfeeding women.
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
30-day major renal adverse events
Time frame: 30-day
Follow-up of patients with prognostic indicators of renal function within 30 days of enrolment, such as blood creatinine and the need for renal replacement therapy.
Renal artery blood flow
Time frame: Day 1,Day 3,Day 5, Day 7
Ultrasound assessment of renal artery resistance index, and renal artery blood flow.
Renal venous return
Time frame: Day 1,Day 3,Day 5, Day 7
Ultrasonographic assessment of renal venous reflux profiles.
renal microcirculation
Time frame: Day 1,Day 3,Day 5, Day 7
Evaluation of renal microcirculation by ultrasonography.
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 9 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Artery Blood Flow, run by Peking Union Medical College 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 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: finished, as of the sponsor's last update on 9 Feb 2024. 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?
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?
30-day major renal adverse events (time frame: 30-day). The study lists 4 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 Feb 2024.