- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06090773
Characteristics of Renal Blood Flow in AKI Patients in ICU and Its Clinical Significance
February 7, 2024 updated by: Peking Union Medical College Hospital
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
96
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rongping Chen, M.S.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Rongping Chen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Acute kidney injury
Patients with acute injuries in ICU patients.
|
Patients with non-acute kidney injury
ICU patients without acute injury patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30-day
|
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.
|
Day 1,Day 3,Day 5, Day 7
|
Renal venous return
Time Frame: Day 1,Day 3,Day 5, Day 7
|
Ultrasonographic assessment of renal venous reflux profiles.
|
Day 1,Day 3,Day 5, Day 7
|
renal microcirculation
Time Frame: Day 1,Day 3,Day 5, Day 7
|
Evaluation of renal microcirculation by ultrasonography.
|
Day 1,Day 3,Day 5, Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Actual)
December 1, 2023
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
October 14, 2023
First Submitted That Met QC Criteria
October 14, 2023
First Posted (Actual)
October 19, 2023
Study Record Updates
Last Update Posted (Actual)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-PUMCH-A-218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
University Hospital, GhentWithdrawn
-
Astellas Pharma IncCompleted
-
South Egypt Cancer InstituteCompletedAcute Kidney Injury (AKI)Egypt
-
Xuzhou Medical UniversityUnknownPostoperative Acute Kidney Injury
-
Assiut UniversityUnknownNeonatal Acute Kidney InjuryEgypt
-
Assiut UniversityUnknownPostoperative Acute Kidney Injury
-
Hospital de BaseFundação de Amparo à Pesquisa do Estado de São PauloUnknownEarly Acute Kidney InjuryBrazil
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalRecruiting