Acute Kidney InjuryNCT03397992
Low Dialysate Temperature During SLED
A study testing Changing dialysate temperature in people with Acute Kidney Injury and Intra-dialytic Hypotension, run by Washington University School of Medicine.
Trial summary
Objectives: This study is evaluating the hemodynamic effects of lowering the dialysate temperature in acute kidney injury (AKI) patients submitted to sustained low efficiency dialysis (SLED) in a single large center. Methods: Participants will be randomly assigned to two treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Intra-dialytic Hypotension
- What is being tested?
- Changing dialysate temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 16 Jan 2017to 22 Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older, AKI stage 3 requiring RRT, maximum two pressers, initial temperature of 36°C or higher.
Who cannot join
- Initial temperature less than 36°C, ESRD, three or more pressers, requirement of antihypertensive medications.
About this study
Official title: Low Dialysate Temperature to Prevent Intradialytic Hypotension During SLED in AKI
Objectives: This study is evaluating the hemodynamic effects of lowering the dialysate temperature in acute kidney injury (AKI) patients submitted to sustained low efficiency dialysis (SLED) in a single large center.
Methods: Participants will be randomly assigned to two treatment groups. One group will be started treatment with low temperature (set point 5 on the machine which is around 35°C) for one treatment and then alternate between high and low temperatures for a maximum of 8 treatments. The other group will be started with high temperature (set point 9 on the machine which is around 37°C) for the first treatment then alternate between high and low temperatures for a maximum of 8 treatments. Each participants will need at least two treatments, one with each temperature to be included in the analysis. The investigators will be looking for the number of events during a SLED treatment. Events will be defined as drop in systolic blood pressure ≥ 20 mmHg or drop in mean arterial pressure (MAP) of ≥10 mmHg, requirement of resuscitation with IVF after initiation of SLED, initiation or increase requirement of vasoactive drugs.
- Conditions
- Acute Kidney Injury, Intra-dialytic Hypotension
- Being tested
- Changing dialysate temperature
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing dialysate temperatureOther
Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Treatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter. Receives: Other: Changing dialysate temperature |
| Group B | Active comparator | Treatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter Receives: Other: Changing dialysate temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intradialytic hypotension episodes with different dialysate temperatures
Hypothesis is that low dialysate temperature will decrease the number of hypotensive episodes during SLED treatment, hypotensive episodes are defined as drop in SBP ≥ 20 mm Hg or MAP ≥ 10 mm Hg, decrease in ultrafiltration rate, increase or start of vasoactive agents or termination of treatment because of hypotension.
Measured: Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality
Secondary outcomes (3)
Effect on baseline body temperature
Change of body temperature during and at end of SLED treatment from baseline temperature measured before starting SLED
Measured: Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality
Effect on total ultrafiltration
The total amount of fluid ordered to be removed will be compared with the amount actually removed
Measured: Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality
Effect on Kt/V
The dialysis dose will be monitored
Measured: Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start16 Jan 2017
- Primary completion22 Apr 2017
- Study completion22 Apr 2017
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 Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahad Edrees, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397992
- Sponsor's protocol ID
- 201612031
- Status last verified
- Jan 2018
- First submitted
- 2 Jan 2018
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edrees FY, Katari S, Baty JD, Vijayan A. A Pilot Study Evaluating the Effect of Cooler Dialysate Temperature on Hemodynamic Stability During Prolonged Intermittent Renal Replacement Therapy in Acute Kidney Injury. Crit Care Med. 2019 Feb;47(2):e74-e80. doi: 10.1097/CCM.0000000000003508.
PubMed 30394919
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dialysate Temperature to Prevent Intradialytic Hypotension During SLED in AKI
- ClinicalTrials.gov ID
- NCT03397992
- Acronym / sponsor ID
- 201612031
- Conditions
- Acute Kidney Injury, Intra-dialytic Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 22 Apr 2017 (actual)
- Study completion
- 22 Apr 2017 (actual)
- First posted
- 12 Jan 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.
Objectives: This study is evaluating the hemodynamic effects of lowering the dialysate temperature in acute kidney injury (AKI) patients submitted to sustained low efficiency dialysis (SLED) in a single large center.
Methods: Participants will be randomly assigned to two treatment groups. One group will be started treatment with low temperature (set point 5 on the machine which is around 35°C) for one treatment and then alternate between high and low temperatures for a maximum of 8 treatments. The other group will be started with high temperature (set point 9 on the machine which is around 37°C) for the first treatment then alternate between high and low temperatures for a maximum of 8 treatments. Each participants will need at least two treatments, one with each temperature to be included in the analysis. The investigators will be looking for the number of events during a SLED treatment. Events will be defined as drop in systolic blood pressure ≥ 20 mmHg or drop in mean arterial pressure (MAP) of ≥10 mmHg, requirement of resuscitation with IVF after initiation of SLED, initiation or increase requirement of vasoactive drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Changing dialysate temperatureTreatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter. |
| Group B | Active comparator | Other: Changing dialysate temperatureTreatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older, AKI stage 3 requiring RRT, maximum two pressers, initial temperature of 36°C or higher.
Key exclusion criteria (1 listed)
- Initial temperature less than 36°C, ESRD, three or more pressers, requirement of antihypertensive medications.
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 |
|---|---|---|
| Changing dialysate temperaturePatients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C) | Other | Group A, Group B |
Primary outcome
Number of intradialytic hypotension episodes with different dialysate temperatures
Time frame: Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality
Hypothesis is that low dialysate temperature will decrease the number of hypotensive episodes during SLED treatment, hypotensive episodes are defined as drop in SBP ≥ 20 mm Hg or MAP ≥ 10 mm Hg, decrease in ultrafiltration rate, increase or start of vasoactive agents or termination of treatment because of hypotension.
3 secondary outcomes
Effect on baseline body temperature
Time frame: Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality
Effect on total ultrafiltration
Time frame: Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality
Effect on Kt/V
Time frame: Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality
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 12 Jan 2018.
- Derived from this study: PubMed 30394919Edrees FY, Katari S, Baty JD, Vijayan A. A Pilot Study Evaluating the Effect of Cooler Dialysate Temperature on Hemodynamic Stability During Prolonged Intermittent Renal Replacement Therapy in Acute Kidney Injury. Crit Care Med. 2019 Feb;47(2):e74-e80. doi: 10.1097/CCM.0000000000003508.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
Not yet recruitingObservational study
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
Biomarkers, Acute Kidney Injury
Recruiting
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Acute Kidney Injury
Recruiting
NIRS Monitoring in the NICU and AKI
Acute Kidney Injury (AKI), Postnatal AKI
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Changing dialysate temperature in people with Acute Kidney Injury and Intra-dialytic Hypotension, run by Washington University School of Medicine.
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 1 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 12 Jan 2018. 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?
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?
Number of intradialytic hypotension episodes with different dialysate temperatures (time frame: Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality). 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 NCT03397992, 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 12 Jan 2018.