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Renal Venous ReturnNCT06159010

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

An observational study of Renal Venous Return, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Renal Venous Return
How many people
110 participants
Where
1 siteChina
Study dates
1 Jan 2023to 1 Nov 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
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking Union Medical College Hospital

    Beijing, None Selected

Other trials in China

About this study

Official title: Relationship Between Renal Venous Return and Prognosis of Renal Function in Patients

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.

Keywords
Ultrasonography, Renal congestion, Renal venous flow, Intrarenal venous flow, Acute kidney injury
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 groups in NCT06159010
Study groupRoleWhat they receive
Acute kidney injuryNot described
Patients with non-acute kidney injuryNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. renal venous flow

    Measured: Day 1,Day 3,Day 5, Day 7

  2. intrarenal venous flow

    Measured: Day 1,Day 3,Day 5, Day 7

  3. center venous pressure

    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.

  1. First posted6 Dec 2023
  2. Study start1 Jan 2023
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

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
Other
Time perspective
Prospective
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06159010
Sponsor's protocol ID
ICU-AKI
Status last verified
Nov 2023
First submitted
28 Nov 2023
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Venous Return, 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 12 Dec 2023. 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?

renal venous flow (time frame: Day 1,Day 3,Day 5, Day 7). The study lists 3 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 12 Dec 2023.

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