Blood PurificationNCT05510713
Blood Purification Therapy With Dual-cannula in Jugular-femoral Venous
A study testing Hemodialysis Catheter in people with Blood Purification and Dual-cannula, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Purification, Dual-cannula, Vena Cava Disconnection
- What is being tested?
- Hemodialysis Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Oct 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Inability to establish suitable vascular access
- 2. Pregnant women
- 3. Not agreeing to active life support treatment
- 4. Severe active bleeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- Blood Purification, Dual-cannula, Vena Cava Disconnection
- Being tested
- Hemodialysis Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodialysis CatheterDevice
We add a dialysis catheter to the patient, i.e., replace single-cannula in femoral venous with dual-cannula in jugular-femoral venous
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Hemodialysis Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
vasoactive drugs
doses of vasoactive drugs
Measured: 144 hours after dual-cannula in jugular-femoral venous
ICU mortality
Measurement of ICU mortality
Measured: 28-day ICU mortality
Secondary outcomes (1)
Cytokine
Checking cytokine levels by laboratory
Measured: 24hous after dual-cannula in jugular-femoral venous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PurificationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minjie Ju, PHD, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510713
- Sponsor's protocol ID
- jv-fv-RRT
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study on the Effect of Blood Purification Therapy With Dual-cannula in Jugular-femoral Venous
- ClinicalTrials.gov ID
- NCT05510713
- Acronym / sponsor ID
- jv-fv-RRT
- Conditions
- Blood Purification, Dual-cannula, Vena Cava Disconnection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Hemodialysis Catheterwe used the dual-cannula in jugular-femoral venous blood purification therapy in the following patients with vena cava disconnection or severe obstruction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 1. Inability to establish suitable vascular access
- 2. Pregnant women
- 3. Not agreeing to active life support treatment
- 4. Severe active bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodialysis CatheterWe add a dialysis catheter to the patient, i.e., replace single-cannula in femoral venous with dual-cannula in jugular-femoral venous | Device | intervention group |
Primary outcome
vasoactive drugs
Time frame: 144 hours after dual-cannula in jugular-femoral venous
doses of vasoactive drugs
ICU mortality
Time frame: 28-day ICU mortality
Measurement of ICU mortality
1 secondary outcome
Cytokine
Time frame: 24hous after dual-cannula in jugular-femoral venous
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minjie Ju, PHD study director
Shanghai Zhongshan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis Catheter in people with Blood Purification and Dual-cannula, run by Shanghai Zhongshan Hospital.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhunyong Gu (8613918677995, gu.zhunyong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vasoactive drugs (time frame: 144 hours after dual-cannula in jugular-femoral venous). The study lists 2 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 22 Aug 2022.