Hypotension During DialysisPhase 4NCT04522635
Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury
A Phase 4 study testing (100 ml of Albumin 25%) in people with Hypotension During Dialysis and Fluid Overload, run by University of California, San Diego.
Trial summary
Hospitalized patients often suffer from an acute shutdown of kidney function secondary to infections, use of antibiotics, or use of intravenous contrast agents. This results in the accumulation of toxic substances and retention of fluid in the body. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypotension During Dialysis, Fluid Overload
- What is being tested?
- (100 ml of Albumin 25%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2015to 31 Dec 2019
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age > 18 years old
- need for intermittent hemodialysis during hospitalization
- hypoalbuminemia (albumin<3g/dl)
Who cannot join
- allergy to the components of albumin
About this study
Hospitalized patients often suffer from an acute shutdown of kidney function secondary to infections, use of antibiotics, or use of intravenous contrast agents. This results in the accumulation of toxic substances and retention of fluid in the body. Dialysis techniques are often needed to manage these patients to remove the retained toxic substances and extra fluid and allow the kidney time to recover. The amount and duration of fluid accumulation have been associated with a higher risk of death and longer hospital stays. Correction of fluid overload with dialysis has been shown to be beneficial in improving the outcomes from these patients. Most patients are quite sick and often have low levels of a blood protein called albumin that makes them more prone to developing low blood pressure during dialysis and limits the ability of dialysis to remove solutes and fluid adequately. Often dialysis sessions are complicated by the development of low blood pressures and symptoms such as nausea, vomiting, and headaches that further compromises dialysis efficacy. In this study, the hypothesis that addition of intravenous albumin during the dialysis session will improve the ability to remove fluid and reduce the incidence of low blood pressure during dialysis thereby improving patient tolerance and the efficacy of the procedure will be tested. Patients with acute kidney failure or end-stage Renal Disease who need dialysis for fluid removal will be allocated to receive albumin or saline as intravenous fluids during individual dialysis sessions and information on how much fluid can be removed and how many complications occur in each session will be recorded. Dialysis sessions with albumin will be compared with those with saline alone to determine the benefit of adding albumin to the treatment. Information obtained from this study will allow physicians to manage patients requiring dialysis for acute kidney failure more effectively and help improve outcomes.
Read the detailed description
This study will address the following questions:
AIM 1: Can the utilization of intravenous albumin enhance the efficacy of fluid removal in hospitalized patients undergoing dialysis for AKI or ESRD.
The hypothesis to be tested:
- Addition of albumin solutions to dialysis therapy will enhance the efficacy of fluid removal (total amount of fluid removed)
- Albumin solutions will improve the efficiency of fluid removal by dialysis per unit time
- Albumin addition will reduce the time to achieving and maintaining fluid balance and correcting fluid overload.
AIM 2: Can the utilization of IV albumin improve the safety of fluid removal during dialysis?
The hypothesis to be tested:
- Addition of albumin solutions will reduce the frequency of Intradialytic hypotension associated with fluid removal on dialysis.
- Albumin solutions given during dialysis will reduce the incidence and magnitude of myocardial stunning associated with fluid removal on dialysis
- Albumin solutions given during dialysis will reduce post-dialysis symptoms AIM 3: Does utilization of IV albumin improve the microcirculation in hospitalized patients undergoing fluid removal with dialysis?
The hypothesis to be tested:
- Patients with AKI or ESRD will have deranged microcirculatory profile as compared to normal
- During fluid removal with dialysis changes in microcirculation correlate with alterations in hemodynamics related to the rate and amount of fluid removal
- Utilization of IV albumin during dialysis will reduce the microcirculatory stress of fluid removal
- Conditions
- Hypotension During Dialysis, Fluid Overload
- Being tested
- (100 ml of Albumin 25%)
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(100 ml of Albumin 25%)Drug
Also called albumin
single dose of 25g albumin (100 ml of Grifols 25%) given intravenously at the start of IHD
| Study group | Role | What they receive |
|---|---|---|
| albumin | Active comparator | albumin (100 ml of Grifols 25%) given intravenously at the start of IHD Receives: Drug: (100 ml of Albumin 25%) |
| normal saline | Placebo comparator | 0.9% sodium chloride (normal saline (NS)) given intravenously at the start of IHD Receives: Drug: (100 ml of Albumin 25%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid removal
achieved fluid removal expressed as ml/kg/hour
Measured: during procedure
Secondary outcomes (1)
hypotension
cardiovascular complications, including hypotensive episodes
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start3 Jun 2015
- Primary completion15 Dec 2017
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypotension During DialysisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be randomized for a minimum of 4 and maximum of 6 consecutive dialysis sessions to one of two sequences: 1. Sequence A: Albumin in sessions 1, 3 and 5 and saline in sessions 2, 4 and 6 2. Sequence B: Saline in sessions 1, 3, 5 and albumin in sessions 2, 4 and 6 Dialysis Procedures (Standard of Care with the exception of Albumin which is additional and for research purposes only): All dialysis sessions will include standard procedures and monitoring. Dialysis prescriptions will be individualized for each patient and will be maintained through each of the 6 sessions.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Responsible party
- Principal investigator, Ravindra Mehta, University of California, San Diego
- Investigators
- Ravindra L Mehta, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522635
- Sponsor's protocol ID
- 141779
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macedo E, Karl B, Lee E, Mehta RL. A randomized trial of albumin infusion to prevent intradialytic hypotension in hospitalized hypoalbuminemic patients. Crit Care. 2021 Jan 6;25(1):18. doi: 10.1186/s13054-020-03441-0.
PubMed 33407747
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT04522635
- Acronym / sponsor ID
- 141779
- Conditions
- Hypotension During Dialysis, Fluid Overload
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Study start
- 3 Jun 2015 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Aug 2020 (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.
Hospitalized patients often suffer from an acute shutdown of kidney function secondary to infections, use of antibiotics, or use of intravenous contrast agents. This results in the accumulation of toxic substances and retention of fluid in the body. Dialysis techniques are often needed to manage these patients to remove the retained toxic substances and extra fluid and allow the kidney time to recover. The amount and duration of fluid accumulation have been associated with a higher risk of death and longer hospital stays. Correction of fluid overload with dialysis has been shown to be beneficial in improving the outcomes from these patients. Most patients are quite sick and often have low levels of a blood protein called albumin that makes them more prone to developing low blood pressure during dialysis and limits the ability of dialysis to remove solutes and fluid adequately. Often dialysis sessions are complicated by the development of low blood pressures and symptoms such as nausea, vomiting, and headaches that further compromises dialysis efficacy. In this study, the hypothesis that addition of intravenous albumin during the dialysis session will improve the ability to remove fluid and reduce the incidence of low blood pressure during dialysis thereby improving patient tolerance and the efficacy of the procedure will be tested. Patients with acute kidney failure or end-stage Renal Disease who need dialysis for fluid removal will be allocated to receive albumin or saline as intravenous fluids during individual dialysis sessions and information on how much fluid can be removed and how many complications occur in each session will be recorded. Dialysis sessions with albumin will be compared with those with saline alone to determine the benefit of adding albumin to the treatment. Information obtained from this study will allow physicians to manage patients requiring dialysis for acute kidney failure more effectively and help improve outcomes.
Detailed description
This study will address the following questions:
AIM 1: Can the utilization of intravenous albumin enhance the efficacy of fluid removal in hospitalized patients undergoing dialysis for AKI or ESRD.
The hypothesis to be tested:
- Addition of albumin solutions to dialysis therapy will enhance the efficacy of fluid removal (total amount of fluid removed)
- Albumin solutions will improve the efficiency of fluid removal by dialysis per unit time
- Albumin addition will reduce the time to achieving and maintaining fluid balance and correcting fluid overload.
AIM 2: Can the utilization of IV albumin improve the safety of fluid removal during dialysis?
The hypothesis to be tested:
- Addition of albumin solutions will reduce the frequency of Intradialytic hypotension associated with fluid removal on dialysis.
- Albumin solutions given during dialysis will reduce the incidence and magnitude of myocardial stunning associated with fluid removal on dialysis
- Albumin solutions given during dialysis will reduce post-dialysis symptoms AIM 3: Does utilization of IV albumin improve the microcirculation in hospitalized patients undergoing fluid removal with dialysis?
The hypothesis to be tested:
- Patients with AKI or ESRD will have deranged microcirculatory profile as compared to normal
- During fluid removal with dialysis changes in microcirculation correlate with alterations in hemodynamics related to the rate and amount of fluid removal
- Utilization of IV albumin during dialysis will reduce the microcirculatory stress of fluid removal
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized for a minimum of 4 and maximum of 6 consecutive dialysis sessions to one of two sequences: 1. Sequence A: Albumin in sessions 1, 3 and 5 and saline in sessions 2, 4 and 6 2. Sequence B: Saline in sessions 1, 3, 5 and albumin in sessions 2, 4 and 6 Dialysis Procedures (Standard of Care with the exception of Albumin which is additional and for research purposes only): All dialysis sessions will include standard procedures and monitoring. Dialysis prescriptions will be individualized for each patient and will be maintained through each of the 6 sessions.
| Arm | Type | Receives |
|---|---|---|
| albumin | Active comparator | Drug: (100 ml of Albumin 25%)albumin (100 ml of Grifols 25%) given intravenously at the start of IHD |
| normal saline | Placebo comparator | Drug: (100 ml of Albumin 25%)0.9% sodium chloride (normal saline (NS)) given intravenously at the start of IHD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years old
- need for intermittent hemodialysis during hospitalization
- hypoalbuminemia (albumin<3g/dl)
Key exclusion criteria (1 listed)
- allergy to the components of albumin
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 |
|---|---|---|
| (100 ml of Albumin 25%)Also: albuminsingle dose of 25g albumin (100 ml of Grifols 25%) given intravenously at the start of IHD | Drug | albumin, normal saline |
Primary outcome
fluid removal
Time frame: during procedure
achieved fluid removal expressed as ml/kg/hour
1 secondary outcome
hypotension
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Derived from this study: PubMed 33407747Macedo E, Karl B, Lee E, Mehta RL. A randomized trial of albumin infusion to prevent intradialytic hypotension in hospitalized hypoalbuminemic patients. Crit Care. 2021 Jan 6;25(1):18. doi: 10.1186/s13054-020-03441-0.
- 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.
Ravindra L Mehta, MD principal investigator
UCSD
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing (100 ml of Albumin 25%) in people with Hypotension During Dialysis and Fluid Overload, run by University of California, San Diego.
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 1 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: finished, as of the sponsor's last update on 24 Aug 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
fluid removal (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522635, which also lists 1 linked publication.
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 24 Aug 2020.