Characteristics of Renal Blood Flow in AKI Patients in ICU and Its Clinical Significance

Acute Kidney Injury Clinical Trial

Official title:

Characteristics of Renal Blood Flow in AKI Patients With Sepsis and Its Clinical Significance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06090773
• Other study ID #: 2022-PUMCH-A-218
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2024
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 ultrasonographic assessment of renal blood flow indices for evaluating prognosis in patients with sepsis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
China	Rongping Chen	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30-day
Primary	Renal artery blood flow	Ultrasound assessment of renal artery resistance index, and renal artery blood flow.	Day 1,Day 3,Day 5, Day 7
Primary	Renal venous return	Ultrasonographic assessment of renal venous reflux profiles.	Day 1,Day 3,Day 5, Day 7
Primary	renal microcirculation	Evaluation of renal microcirculation by ultrasonography.	Day 1,Day 3,Day 5, Day 7