Renal Replacement TherapyPhase 2SAFER-SLEDNCT03665311
Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis Feasibility Study
A Phase 2 study testing 25% Albumin fluid and Normal Saline in people with Renal Replacement Therapy and Acute Kidney Injury, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Objective: The primary aim of this 60 patient feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Replacement Therapy, Acute Kidney Injury, Hypotension
- What is being tested?
- 25% Albumin fluid and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 25 Mar 2019to 15 Jan 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 yrs;
- AKI treated with SLED (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines48).
Who cannot join
- SLED initiated for non AKI-related indication (i.e. concurrent intoxication; treatment of hypothermia);
- receiving chronic dialysis treatments;
- history of allergic reaction to albumin;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis (SAFER-SLED): A Feasibility Study
Objective: The primary aim of this 60 patient feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol.
Read the detailed description
Background: Intravenous albumin (25%) boluses are frequently given to critically ill patients during slow low-efficiency dialysis (SLED) treatments for acute kidney injury (AKI). The intention of giving albumin during SLED is to stabilize the blood pressure to permit more aggressive overall fluid removal with ultrafiltration; however, there is little evidence to support this expensive practice.
Objective: The primary aim of this feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol.
The results of this feasibility trial will help us to plan and carry out a multicentre pilot trial comparing the efficacy of the interventions in achieving fluid removal in critically ill patients with AKI on SLED.
Design: A randomized controlled trial with two parallel arms. Setting: The mixed medical-surgical intensive care units of a Canadian tertiary care hospital.
Study Population: 60 patients with AKI requiring treatment with SLED (by definition, Kidney Disease Improving Global Outcomes (KDIGO) stage 3 AKI). Intervention: Participants will be randomized to receive either albumin (25%) boluses or normal saline placebo boluses during their SLED treatments.
- Conditions
- Renal Replacement Therapy, Acute Kidney Injury, Hypotension
- Being tested
- 25% Albumin fluid, Normal Saline
- Keywords
- Albumin, Normal Saline, Dialysis, Intensive Care Unit
- Medical subject headings
- Acute Kidney Injury, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25% Albumin fluidBiological
25% Albumin fluid (100 mL)
Normal SalineOther
0.9% Normal Saline (100 mL)
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | 100 mL 0.9% Normal Saline at the initiation of SLED and another 100 mL 0.9% Normal Saline after 4 hours of treatment Receives: Other: Normal Saline |
| 25% Albumin fluid | Active comparator | 100 mL 25% Albumin fluid at the initiation of SLED and another 100 mL 25% Albumin fluid after 4 hours of treatment Receives: Biological: 25% Albumin fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Percentage of eligible patients that are successfully recruited into the study
Measured: 24 months
Secondary outcomes (6)
Adherence to intervention
Percentage of SLED sessions in which patients received their allocated intervention (or placebo).
Measured: Through study completion, on average 1 year.
Completeness of follow-up
Percentage of patients who have complete data available with respect to the primary and other secondary outcomes at the end of the study.
Measured: 24 months
Volume removal achieved during SLED sessions
Overall fluid removal (i.e. percentage of target ultrafiltration achieved)calculated as the actual ultrafiltration volume divided by the target (ordered) ultrafiltration volume).
Measured: Through study completion, on average 1 year.
New or increased vasopressor use during SLED sessions
Initiation or any increase in vasopressor dose(s) before the completion of a SLED session relative to the start.
Measured: Through study completion, on average 1 year.
Change in mean arterial blood pressure (MAP) < 55 mmHg during SLED sessions
Percentage of SLED sessions during which patients' MAP (defined as [(2X diastolic blood pressure) + systolic blood pressure]/3) falls to <55 mmHg at any time during the SLED session.
Measured: Through study completion, on average 1 year.
Change in MAP of >=20 mmHg during the SLED sessions.
Percentage of SLED sessions during which patients' MAP falls by >=20 mmHg relative to their MAP at the start of the SLED session.
Measured: Through study completion, on average 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start25 Mar 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Replacement TherapyStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with two parallel arms 1:1
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward G Clark, MD, MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665311
- Sponsor's protocol ID
- CRRF 316
- Acronym
- SAFER-SLED
- Status last verified
- Jun 2020
- First submitted
- 19 Jul 2018
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Clark EG, McIntyre L, Watpool I, Kong JWY, Ramsay T, Sabri E, Canney M, Hundemer GL, Brown PA, Sood MM, Hiremath S. Intravenous albumin for the prevention of hemodynamic instability during sustained low-efficiency dialysis: a randomized controlled feasibility trial (The SAFER-SLED Study). Ann Intensive Care. 2021 Dec 13;11(1):174. doi: 10.1186/s13613-021-00962-x.
PubMed 34902089Clark EG, McIntyre L, Ramsay T, Tinmouth A, Knoll G, Brown PA, Watpool I, Porteous R, Montroy K, Harris S, Kong J, Hiremath S. Saline versus albumin fluid for extracorporeal removal with slow low-efficiency dialysis (SAFER-SLED): study protocol for a pilot trial. Pilot Feasibility Stud. 2019 May 30;5:72. doi: 10.1186/s40814-019-0460-3. eCollection 2019.
PubMed 31161046
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis (SAFER-SLED): A Feasibility Study
- ClinicalTrials.gov ID
- NCT03665311
- Acronym / sponsor ID
- SAFER-SLED / CRRF 316
- Conditions
- Renal Replacement Therapy, Acute Kidney Injury, Hypotension
- Keywords
- Albumin, Normal Saline, Dialysis, Intensive Care Unit
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 11 Sep 2018 (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.
Objective: The primary aim of this 60 patient feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol.
Detailed description
Background: Intravenous albumin (25%) boluses are frequently given to critically ill patients during slow low-efficiency dialysis (SLED) treatments for acute kidney injury (AKI). The intention of giving albumin during SLED is to stabilize the blood pressure to permit more aggressive overall fluid removal with ultrafiltration; however, there is little evidence to support this expensive practice.
Objective: The primary aim of this feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol.
The results of this feasibility trial will help us to plan and carry out a multicentre pilot trial comparing the efficacy of the interventions in achieving fluid removal in critically ill patients with AKI on SLED.
Design: A randomized controlled trial with two parallel arms. Setting: The mixed medical-surgical intensive care units of a Canadian tertiary care hospital.
Study Population: 60 patients with AKI requiring treatment with SLED (by definition, Kidney Disease Improving Global Outcomes (KDIGO) stage 3 AKI). Intervention: Participants will be randomized to receive either albumin (25%) boluses or normal saline placebo boluses during their SLED treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial with two parallel arms 1:1
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Other: Normal Saline100 mL 0.9% Normal Saline at the initiation of SLED and another 100 mL 0.9% Normal Saline after 4 hours of treatment |
| 25% Albumin fluid | Active comparator | Biological: 25% Albumin fluid100 mL 25% Albumin fluid at the initiation of SLED and another 100 mL 25% Albumin fluid after 4 hours of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18 yrs;
- AKI treated with SLED (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines48).
Key exclusion criteria (4 listed)
- SLED initiated for non AKI-related indication (i.e. concurrent intoxication; treatment of hypothermia);
- receiving chronic dialysis treatments;
- history of allergic reaction to albumin;
- pregnancy.
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 |
|---|---|---|
| 25% Albumin fluid25% Albumin fluid (100 mL) | Biological | 25% Albumin fluid |
| Normal Saline0.9% Normal Saline (100 mL) | Other | Normal Saline |
Primary outcome
Recruitment rate
Time frame: 24 months
Percentage of eligible patients that are successfully recruited into the study
6 secondary outcomes
Adherence to intervention
Time frame: Through study completion, on average 1 year.
Completeness of follow-up
Time frame: 24 months
Volume removal achieved during SLED sessions
Time frame: Through study completion, on average 1 year.
New or increased vasopressor use during SLED sessions
Time frame: Through study completion, on average 1 year.
Change in mean arterial blood pressure (MAP) < 55 mmHg during SLED sessions
Time frame: Through study completion, on average 1 year.
Change in MAP of >=20 mmHg during the SLED sessions.
Time frame: Through study completion, on average 1 year.
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 17 Jun 2020.
- Derived from this study: PubMed 34902089Clark EG, McIntyre L, Watpool I, Kong JWY, Ramsay T, Sabri E, Canney M, Hundemer GL, Brown PA, Sood MM, Hiremath S. Intravenous albumin for the prevention of hemodynamic instability during sustained low-efficiency dialysis: a randomized controlled feasibility trial (The SAFER-SLED Study). Ann Intensive Care. 2021 Dec 13;11(1):174. doi: 10.1186/s13613-021-00962-x.
- Derived from this study: PubMed 31161046Clark EG, McIntyre L, Ramsay T, Tinmouth A, Knoll G, Brown PA, Watpool I, Porteous R, Montroy K, Harris S, Kong J, Hiremath S. Saline versus albumin fluid for extracorporeal removal with slow low-efficiency dialysis (SAFER-SLED): study protocol for a pilot trial. Pilot Feasibility Stud. 2019 May 30;5:72. doi: 10.1186/s40814-019-0460-3. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
Edward G Clark, MD, MSc principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 25% Albumin fluid and Normal Saline in people with Renal Replacement Therapy and Acute Kidney Injury, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 2 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: finished, as of the sponsor's last update on 17 Jun 2020. 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 Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Recruitment rate (time frame: 24 months). 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 NCT03665311, which also lists 2 linked publications.
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 17 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.