Analysis of changes in duplex sonographic renal congestion parameters after large-volume paracentesis in patients with massive symptomatic ascites

Analysis of changes in duplex sonographic renal congestion parameters after large-volume paracentesis in patients with massive symptomatic ascites - ASCIREN – ASCItes and RENal Venous Congestion: Duplex Ultrasound Analysis Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038860

Enrollment

Registered

2026-01-05

Start date

2026-02-09

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congestive nephropathy

Interventions

Group 1: Analysis of duplex sonographic parameters of renal congestion prior to large-volume paracentesis in patients with massive symptomatic ascites Group 2: Analysis of duplex sonographic parameter

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Symptomatic massive ascites with indication (independent of this study) for therapeutic relief - Legal age - Signed consent form for this study - Voluntary participation, capacity to consent

Exclusion criteria

Exclusion criteria: - Refusal to undergo the examination/participate in the study - Inability to cooperate during the ultrasound examination - Minor age - Pregnancy or breastfeeding - Circumstances that prevent the performance or interpretation of a duplex ultrasound examination (e.g., severe dyspnea/tachypnea)

Design outcomes

Primary

Measure	Time frame
- Resistance Index (RI) - Venous flow pattern (continuous—no congestion vs. discontinuous: pulsatile mild, biphasic moderate, and monophasic severe congestion) - Venous impedance index (VII) - Cardiac cycle (CC) - Venous flow (VF) - Renal venous stasis index (RVSI = (CC-VF)/CC) - Venous velocity index (VVI (max. pos./max. neg.)) - Inferior vena cava (VCI max., VCI insp.)	—

Secondary

Measure	Time frame
1. Prevalence of renal congestion in this patient group 2. Subgroup analysis of primary endpoints in patients with cirrhosis vs. no cirrhosis 3. Correlation of renal congestion with renal function parameters (creatinine, eGFR) 4. Amount of ascites removed (ml) and correlation of the amount of ascites removed with changes in duplex parameters 5. Smallest fluid depth (SFD; mm) (=distance from peritoneum to intestinal loop at puncture site in supine position in mm) before paracentesis and after paracentesis (surrogate for the amount of ascites and amount of residual ascites after paracentesis) 6. VCI diameter (inferior vena cava) before and after paracentesis 7. Blood pressure and heart rate before and after paracentesis	—

Measure

Time frame

1. Prevalence of renal congestion in this patient group 2. Subgroup analysis of primary endpoints in patients with cirrhosis vs. no cirrhosis 3. Correlation of renal congestion with renal function parameters (creatinine, eGFR) 4. Amount of ascites removed (ml) and correlation of the amount of ascites removed with changes in duplex parameters 5. Smallest fluid depth (SFD; mm) (=distance from peritoneum to intestinal loop at puncture site in supine position in mm) before paracentesis and after paracentesis (surrogate for the amount of ascites and amount of residual ascites after paracentesis) 6. VCI diameter (inferior vena cava) before and after paracentesis 7. Blood pressure and heart rate before and after paracentesis

—

Countries

Germany

Contacts

Public ContactMichael Koziolek

Universitätsmedizin Göttingen

mkoziolek@med.uni-goettingen.de00495513960460

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026