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CompletedNCT06159010Updated Dec 12, 2023

Relationship Between Renal Venous Return and Prognosis of Renal Function in Patients With AKI in ICU

An observational study in Renal Venous Return, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by Peking Union Medical College Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
110
Ages
18 Years to 85 Years
Sex
All
01

Study summary

A single-center prospective longitudinal observational study was carried out. Assessments were made on Days 1, 3, 5, and 7 after ICU admission in 90 patients with sepsis AKI, and 19 patients with septic without AKI only made assessments on Day 1. The primary outcome was CVP obtained at the time of renal ultrasonography. The association among RVF patterns, IRVF patterns, and CVP was examined using Student's t-test, and that with composite outcomes was assessed using a generalized estimating equation analysis, to account for intra-individual correlations.

Read the detailed description

The prospective observational study was conducted at the ICU in China. The study was approved by the institutional review board of Peking Union Medical College Hospital (approval number, I-23PJ1176). All procedures were performed in accordance with the ethical standards of the local ethics committee on human experimentation and with the Helsinki Declaration of 1975.

Study participants

A single-center prospective longitudinal observational study is carried out at a tertiary critical care unit in China. Serial assessments were made of the renal RVF, IRVF, and CVP at 4-time points: Day one (D1) within 24 h of ICU admission, D1 + 48 h (D3), D1 + 96h (D5) and D1 + 144h (D7). Only adult patients (> 18 years) were included. AKI was staged using KDIGO criteria. Common to AKI research, the baseline creatinine value may not be known, and therefore defining AKI biochemically is not always possible. For those who had AKI defined using creatinine, we used the lowest value of any form within the 12 months prior to admission as a baseline value. If no preadmission creatinine was available, the lowest value the creatinine returned to after the resolution of acute illness was used. Failing all the above and if AKI could not be staged by other criteria, the admission creatinine was used as the baseline value. We excluded patients who (i) were on maintenance dialysis for chronic renal failure, (ii) were pregnant, (iii) had any ureteral obstructions because these affect the IRVF waveforms, and (vi) had earlier participation in this study.

Renal ultrasonography

The technical aspects of renal ultrasonography are as follows. Using a sector transducer, the right kidney in the left lateral supine position. Color Doppler images were used to determine a target renal and intrarenal vein. The RVF waveforms (the flow away from the transducer below the baseline) were classified into four waveform patterns: continuous or discontinuous (inclusion Biphasic continuous, Biphasic separated, and Monophasic). Specifically, a continuous pattern corresponded to the presence of continuous, uninterrupted venous flow below the baseline throughout the cardiac cycle, whereas the discontinuous pattern was a group of patterns that had at least one phase with zero velocity in venous flow during a cardiac cycle. The venous impedance index (VII), that is, the proportion of reduction in venous flow from its peak velocity (very low [0.2] in healthy subjects), was calculated as the peak maximum flow velocity minus the maximum flow velocity at the nadir in veins divided by the maximum flow velocity. The renal venous stasis index (RVSI) was calculated as the index cardiac cycle time minus the renal venous flow time divided by the index cardiac cycle time. In patients with sinus rhythm, we measured all indices over three cardiac cycles at the end of expiration and averaged them. In patients with atrial fibrillation, we measured the indices at a cardiac cycle where two preceding cardiac cycles had nearly equal durations. Echocardiography was performed at the bedside in the ICU. Meantime, CVP was measured.

02

Conditions studied

  • Renal Venous Return

Keywords

  • Ultrasonography
  • Renal congestion
  • Renal venous flow
  • Intrarenal venous flow
  • Acute kidney injury
03

In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Only adult patients (> 18 years) were included. AKI was staged using KDIGO criteria. Common to AKI research, the baseline creatinine value may not be known and therefore defining AKI biochemically is not always possible. For those who had AKI defined using creatinine, we used the lowest value of any form within the 12 months prior to admission as a baseline value. If no preadmission creatinine was available, the lowest value the creatinine returned to after the resolution of acute illness was used. Failing all the above and if AKI could not be staged by other criteria, the admission creatinine was used as the baseline value. We excluded patients who (i) were on maintenance dialysis for chronic renal failure, (ii) were pregnant, (iii) had any ureteral obstructions because these affect the IRVF waveforms, and (vi) had earlier participation in this study.

Inclusion criteria

  • Adult patients( > 18 years) were included. AKI was staged using KDIGO criteria. Common to AKI research, the baseline creatinine value may not be known and therefore defining AKI biochemically is not always possible. For those who had AKI defined using creatinine.

Exclusion criteria

Exclusion Criteria:

  • patients who were on maintenance dialysis for chronic renal failure, were pregnant, had any ureteral obstructions because these affect the IRVF waveforms, had earlier participation in this study.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
110 participants (actual)
Patient registry
No

Groups and cohorts

  • Acute kidney injury
  • Patients with non-acute kidney injury
06

What researchers measure

Primary outcomes

  1. renal venous flow

    Time frame: Day 1,Day 3,Day 5, Day 7

  2. intrarenal venous flow

    Time frame: Day 1,Day 3,Day 5, Day 7

  3. center venous pressure

    Time frame: Day 1,Day 3,Day 5, Day 7

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, None Selected, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06159010
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Dec 6, 2023
Start date
Jan 1, 2023
Primary completion
Nov 1, 2023
Completion
Nov 1, 2023
Last update
Dec 12, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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