Blood Purification Therapy With Dual-cannula in Jugular-femoral Venous

August 19, 2022 updated by: Shanghai Zhongshan Hospital

Preliminary Study on the Effect of Blood Purification Therapy With Dual-cannula in Jugular-femoral Venous

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 1. Inability to establish suitable vascular access
  • 2. Pregnant women
  • 3. Not agreeing to active life support treatment
  • 4. Severe active bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: the treatment-as-usual group
we used the single-cannula in femoral venous blood purification therapy in the following patients with vena cava disconnection or severe obstruction
Experimental: intervention group
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
We add a dialysis catheter to the patient, i.e., replace single-cannula in femoral venous with dual-cannula in jugular-femoral venous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vasoactive drugs
Time Frame: 144 hours after dual-cannula in jugular-femoral venous
doses of vasoactive drugs
144 hours after dual-cannula in jugular-femoral venous
ICU mortality
Time Frame: 28-day ICU mortality
Measurement of ICU mortality
28-day ICU mortality

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokine
Time Frame: 24hous after dual-cannula in jugular-femoral venous
Checking cytokine levels by laboratory
24hous after dual-cannula in jugular-femoral venous

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Director: Minjie Ju, PHD, Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • jv-fv-RRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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