NCT05510713

Brief Summary

Acute kidney failure (AKI) is one of the most important causes of morbidity and mortality for critical ill patients. The use of blood purification treatment such as renal replacement therapy (CRRT) and plasma exchange has gradually developed into an effective treatment. However, the efficiency of blood purification may be affected by the recirculation of dual-lumen venous catheter for some special patients including patients with vena cava reflux disorder from massive occupations or ascites. For extreme cases like patients with vena cava disconnection or severe obstruction, the traditional blood purification treatment cannot work effectively. Thus, we used the dual-cannula in jugular-femoral venous blood purification therapy in the following two patients and found that it can improve the perfusion of systemic circulation and the prognosis of patients

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

August 18, 2022

Last Update Submit

August 19, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • vasoactive drugs

    doses of vasoactive drugs

    144 hours after dual-cannula in jugular-femoral venous

  • ICU mortality

    Measurement of ICU mortality

    28-day ICU mortality

Secondary Outcomes (1)

  • Cytokine

    24hous after dual-cannula in jugular-femoral venous

Study Arms (2)

the treatment-as-usual group

NO INTERVENTION

we used the single-cannula in femoral venous blood purification therapy in the following patients with vena cava disconnection or severe obstruction

intervention group

EXPERIMENTAL

we used the dual-cannula in jugular-femoral venous blood purification therapy in the following patients with vena cava disconnection or severe obstruction

Device: Hemodialysis Catheter

Interventions

We add a dialysis catheter to the patient, i.e., replace single-cannula in femoral venous with dual-cannula in jugular-femoral venous

intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. patients requiring haemodilution therapy for various reasons (acute renal failure, acute liver failure, etc.)
  • \. presence of superior vena cava and/or inferior vena cava reflux disorders
  • \. age greater than 18 years

You may not qualify if:

  • \. Inability to establish suitable vascular access
  • \. Pregnant women
  • \. Not agreeing to active life support treatment
  • \. Severe active bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Minjie Ju, PHD

    Shanghai Zhongshan Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 22, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share