End-stage Renal DiseaseNCT06373575
IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure
A study testing Lung and inferior vena cava ultrasound guidance and Conventional protocol guidance in people with End-stage Renal Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Lung and inferior vena cava ultrasound guidance and Conventional protocol guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Jun 2025
- 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
- patients meet the diagnostic criteria for end-stage renal disease;
- indications that the patient may be experiencing signs and/or symptoms of heart failure, and based on the serum N-terminal pro-brain natriuretic peptide level of greater than 11,215. 2 ng/L;
- patients may require prolonged intermittent renal replacement therapy due to volume overload;
- patients ≥18 yo and ≤80 yo;
- either the patient or a family member signs the informed consent;
- patients will undergo at least two sessions of prolonged hemodialysis.
Who cannot join
- history of malignancy or psychiatric disease;
- patients with a history of congenital heart disease or hypertrophic cardiomyopathy;
- coagulation abnormalities, intracranial, visceral or gastrointestinal bleeding in the past 3 months, or contraindications to heparin anticoagulation;
- The duration of prolonged hemodialysis <8 hours;
- Ultrasound unable to monitor the inferior vena cava, or can't access the date;
- Pregnancy;
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- Patients with severe respiratory failure;
- Patients with combined severe infections, such as patients with sepsis;
- Presence of pre-dialysis hypotension: systolic blood pressure <90 mmHg;
- other conditions deemed ineligible by physicians.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inferior Vena Cava and Lung Ultrasound B-lines Guided Decongestion in Critically Ill Kidney Failure Patients With Heart Failure: a Single-center, Prospective, Randomized Controlled Intervention Study
The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term.
Read the detailed description
The point-of-care ultrasound was thought useful in the management of fluid in critically ill patients. At present, the role of the lung and inferior vena cava ultrasound is unclear in the management of decongestion of heart failure in kidney failure (KF) patients using prolonged hemodialysis. The investigators aim to explore the effect of pre-dialysis probing with the lung and inferior vena cava to guide fluid removal as compared with conventional protocols on the improvement of heart failure symptoms in patients with KF with heart failure under prolonged hemodialysis in the short-term.
- Conditions
- End-stage Renal Disease
- Being tested
- Lung and inferior vena cava ultrasound guidance, Conventional protocol guidance
- Keywords
- Kidney Failure, Chronic, heart failure
- Medical subject headings
- Kidney Failure, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung and inferior vena cava ultrasound guidanceProcedure or surgery
The lung and inferior vena cava ultrasound will be utilized as guidance for the development of a dialysis prescription for prolonged hemodialysis.
Conventional protocol guidanceProcedure or surgery
Fluid removal using conventional protocol including blood pressure and physical examination
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Fluid removal with the guidance of lung and inferior vena cava ultrasound before prolonged hemodialysis Receives: Procedure: Lung and inferior vena cava ultrasound guidance |
| Control group | Active comparator | Fluid removal with the conventional protocol Receives: Procedure: Conventional protocol guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pulmonary congestion score
Measured: within 72 hours following randomization
Improvement in heart failure symptoms score
Measured: within 72 hours following randomization
Secondary outcomes (9)
Total ultrafiltration volume
Measured: within 72 hours following randomization
Mean ultrafiltration rate during prolonged hemodialysis
Measured: within 72 hours following randomization
Fluid balance (total outflow - total inflow)
Measured: within 72 hours following randomization
Lung B-line reduction
Measured: within 72 hours following randomization
The change of width of inferior vena cava
Measured: within 72 hours following randomization
Incidence of hypotension during prolonged hemodialysis
Measured: within 72 hours following randomization
Blood pressure variability during the prolonged hemodialysis
Measured: within 72 hours following randomization
In-hospital mortality
Measured: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days
Length of hospital stay
Measured: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Buyun Wu, PhD, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373575
- Sponsor's protocol ID
- 2023-SR-891
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Vena Cava and Lung Ultrasound B-lines Guided Decongestion in Critically Ill Kidney Failure Patients With Heart Failure: a Single-center, Prospective, Randomized Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT06373575
- Acronym / sponsor ID
- 2023-SR-891
- Conditions
- End-stage Renal Disease
- Keywords
- Kidney Failure, Chronic, heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Apr 2024 (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.
The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term.
Detailed description
The point-of-care ultrasound was thought useful in the management of fluid in critically ill patients. At present, the role of the lung and inferior vena cava ultrasound is unclear in the management of decongestion of heart failure in kidney failure (KF) patients using prolonged hemodialysis. The investigators aim to explore the effect of pre-dialysis probing with the lung and inferior vena cava to guide fluid removal as compared with conventional protocols on the improvement of heart failure symptoms in patients with KF with heart failure under prolonged hemodialysis in the short-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Lung and inferior vena cava ultrasound guidanceFluid removal with the guidance of lung and inferior vena cava ultrasound before prolonged hemodialysis |
| Control group | Active comparator | Procedure: Conventional protocol guidanceFluid removal with the conventional protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients meet the diagnostic criteria for end-stage renal disease;
- indications that the patient may be experiencing signs and/or symptoms of heart failure, and based on the serum N-terminal pro-brain natriuretic peptide level of greater than 11,215. 2 ng/L;
- patients may require prolonged intermittent renal replacement therapy due to volume overload;
- patients ≥18 yo and ≤80 yo;
- either the patient or a family member signs the informed consent;
Key exclusion criteria (10 listed)
- history of malignancy or psychiatric disease;
- patients with a history of congenital heart disease or hypertrophic cardiomyopathy;
- coagulation abnormalities, intracranial, visceral or gastrointestinal bleeding in the past 3 months, or contraindications to heparin anticoagulation;
- The duration of prolonged hemodialysis <8 hours;
- Ultrasound unable to monitor the inferior vena cava, or can't access the date;
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 |
|---|---|---|
| Lung and inferior vena cava ultrasound guidanceThe lung and inferior vena cava ultrasound will be utilized as guidance for the development of a dialysis prescription for prolonged hemodialysis. | Procedure or surgery | Intervention group |
| Conventional protocol guidanceFluid removal using conventional protocol including blood pressure and physical examination | Procedure or surgery | Control group |
Primary outcome
Improvement in pulmonary congestion score
Time frame: within 72 hours following randomization
Improvement in heart failure symptoms score
Time frame: within 72 hours following randomization
9 secondary outcomes
Total ultrafiltration volume
Time frame: within 72 hours following randomization
Mean ultrafiltration rate during prolonged hemodialysis
Time frame: within 72 hours following randomization
Fluid balance (total outflow - total inflow)
Time frame: within 72 hours following randomization
Lung B-line reduction
Time frame: within 72 hours following randomization
The change of width of inferior vena cava
Time frame: within 72 hours following randomization
Incidence of hypotension during prolonged hemodialysis
Time frame: within 72 hours following randomization
Blood pressure variability during the prolonged hemodialysis
Time frame: within 72 hours following randomization
In-hospital mortality
Time frame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days
Length of hospital stay
Time frame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- 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.
Buyun Wu, PhD, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung and inferior vena cava ultrasound guidance and Conventional protocol guidance in people with End-stage Renal Disease, run by The First Affiliated Hospital with Nanjing Medical University 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 6 inclusion and 10 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 18 Apr 2024. 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?
Results are not available in the source record.
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?
Improvement in pulmonary congestion score (time frame: within 72 hours following randomization). 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 18 Apr 2024.