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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06090773

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Renal Artery Blood Flow Renal Venous Return Renal Microcirculation

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Acute kidney injury Patients with acute injuries in ICU patients.
Patients with non-acute kidney injury ICU patients without acute injury patients.

Outcome Measures

Primary Outcome Measures

30-day major renal adverse events [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 [Day 1,Day 3,Day 5, Day 7]
Ultrasound assessment of renal artery resistance index, and renal artery blood flow.
Renal venous return [Day 1,Day 3,Day 5, Day 7]
Ultrasonographic assessment of renal venous reflux profiles.
renal microcirculation [Day 1,Day 3,Day 5, Day 7]
Evaluation of renal microcirculation by ultrasonography.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rongping Chen	Beijing	Beijing	China	100730

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT06090773

Other Study ID Numbers:

2022-PUMCH-A-218

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Kidney Injury

Study Results

No Results Posted as of Oct 19, 2023