Acute Kidney InjuryPhase 2NCT04103307
Continuous Renal Replacement Therapy for Acute Kidney Injury by Cooling Blood
A Phase 2 study testing Dialysis cooling in people with Acute Kidney Injury and Continuous Renal Replacement Therapy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and is associated with longer hospital stays and worse survival. The mortality rate of critically ill patients in the ICU who receive renal replacement therapy for AKI ranges between 50-80%, cardiovascular disease being the second largest cause… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Continuous Renal Replacement Therapy
- What is being tested?
- Dialysis cooling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2020to 31 Dec 2022
- 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
- AKI as defined by 2012 AKI KDIGO guidelines requiring CRRT.
- Patient's core temperature between 35°C and 40°C at the time of recruitment.
- Age 18 years old and older.
Who cannot join
- Hypothermia (patient core temperature <35°C) at the time of recruitment
- Extreme hyperthermia or hyperpyrexia (patient core temperature >40°C) at the time of recruitment.
- Contraindication to cooling (e.g., hemorrhagic shock or severe coagulopathy)
- Patients undergoing targeted temperature management for cardiac arrest.
- Chronic kidney disease stage 5 as defined by CKD KDIGO guidelines [19] requiring renal replacement therapy prior to recruitment.
- Receiving palliative care or immediate plans for withdrawal of life sustaining therapy at the time of recruitment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Outcomes in Patients Receiving Continuous Renal Replacement Therapy for Acute Kidney Injury by Cooling Blood in the Dialysis Circuit (CRRiTiCool): a Randomized Controlled Trial
Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and is associated with longer hospital stays and worse survival. The mortality rate of critically ill patients in the ICU who receive renal replacement therapy for AKI ranges between 50-80%, cardiovascular disease being the second largest cause of death. A previous pilot study from the investigator's group showed that myocardial stunning occurs in AKI patients during continuous renal replacement therapy (CRRT) and may explain the high cardiovascular mortality in this population. In the chronic intermittent dialysis setting, mild dialysate cooling was shown to improve intradialytic hemodynamic stability and prevent myocardial stunning. The aim of this study is to find out whether cooling the blood in the CRRT circuit is an effective intervention to prevent myocardial stunning in AKI patients undergoing CRRT and improve patient outcomes.
Read the detailed description
This is a single center, prospective, randomized, open label, controlled trial comparing standard-of-care temperature management with blood cooling CRRT. We will recruit approximately 140 patients (70 in each group) from the Medical Surgical Intensive Care Unit at University Hospital and The Critical Care Trauma Center at Victoria Hospital in London, Ontario.
The study team will randomize patients with acute kidney injury requiring continuous dialysis therapy into one of two groups; either to standard of care continuous dialysis therapy or to cool blood continuous dialysis therapy. All therapy will be delivered using the Baxter PrisMaxTM CRRT machine with TherMaxTM blood warmer.
All participants will undergo a series of echocardiograms (ultrasound of your heart) prior to continuous dialysis therapy initiation, 4-12 hours into therapy, for up to 7 days after therapy initiation, and at discharge from the intensive care unit. Blood work will be collected at 4 time points, prior to continuous dialysis therapy initiation, 4-12 hours into therapy, 24 hours into therapy, and at ICU discharge.
Hourly nasopharyngeal and skin temperatures will be collected. Oral temperature will be collected every four hours.
- Being tested
- Dialysis cooling
- Keywords
- Cooling, CRRT
- 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.
Dialysis coolingProcedure or surgery
Cooling the blood in the CRRT circuit during delivery
| Study group | Role | What they receive |
|---|---|---|
| Control: Standard of care | No intervention | Participants in the control group will receive standard-of-care CRRT prescriptions, and have the returning venous blood warmed with an external blood warmer to a temperature of 37°C. The blood warmer temperature will be adjusted by the CRRT nurse as per usual practice to maintain normothermia. |
| Intervention: Cooling | Experimental | Participants in the intervention group will receive standard of care CRRT prescriptions and have the blood warmer set to 35.5°C, as long as the nasopharyngeal temperature remains above 35.5°C. Receives: Procedure: Dialysis cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Wall Motion Abnormalities
Number of segments undergoing a 20% reduction in longitudinal systolic strain
Measured: At the end of delivery of cool blood during continuous dialysis; 12 to 24 hours
Secondary outcomes (16)
Regional Wall Motion Abnormalities at 7 days
Number of segments undergoing a 20% reduction in longitudinal systolic strain after delivery of cool blood during continuous dialysis
Measured: Seven days after the start of cool blood delivery during continuous dialysis
Regional Wall Motion Abnormalities at ICU discharge
Number of segments undergoing a 20% reduction in longitudinal systolic strain at ICU discharge
Measured: At ICU discharge, an average of 60 days after the start of cool blood delivery during continuous dialysis
Duration of Continuous Renal Replacement Therapy (CRRT)
Number of hours of CRRT therapy during ICU admission
Measured: Through study completion, an average of 60 days
Renal Recovery at 7 days after cool blood continuous dialysis requiring acute kidney injury
Renal recovery may best be defined as a reduction in AKI stage at seven days after the start of cool blood continuous dialysis treatment determined by creatinine level and urine output.
Measured: Seven days after the start of cool blood delivery during continuous dialysis
Renal Recovery at 24 hours after cool blood continuous dialysis requiring acute kidney injury
Renal recovery may best be defined as a reduction in AKI stage at 24 hours after the start of cool blood continuous dialysis treatment determined by creatinine level and urine output.
Measured: 24 hours after the start of cool blood delivery during continuous dialysis
Low blood pressure
Systolic blood pressure less than 90mmHg or more than 20mmHg fall below baseline; 10% increase in vasopressor dose leading to an increase in blood pressure.
Measured: Through study completion, an average of 60 days
Cumulative vasopressor dose
Dose of vasopressor drugs - unit dependent on drug
Measured: Through study completion, an average of 60 days
Patient's Core Body Temperature (Celsius degrees)
Core body temperature as measured with SpotOn device
Measured: Through study completion, an average of 60 days
Temperature of venous blood in return line (Celsius degrees)
Blood temperature measured with SpotOn device
Measured: Through study completion, an average of 60 days
Intensive care unit free days
Number of days that a participant has been discharged from the ICU while admitted to the hospital
Measured: After an average of 60 days in the ICU
ICU length of stay
Number of days a participant stayed in the ICU
Measured: Through study completion, an average of 60 days
Hospital length of stay
Number of days a participant stayed in the hospital
Measured: Through study completion, an average of 60 days to hospital discharge
ICU mortality
Mortality rate during ICU admission
Measured: Through study completion, an average of 60 days
In Hospital Mortality
Mortality rate during in hospital stay
Measured: Through study completion, an average of 60 days to hospital discharge
60-day Mortality
Mortality rate within the 60 day period
Measured: From study start to up to 60 days from study start
Temperature correlation between nasopharyngeal, forehead, and oral temperature measurements
To correlate invasive measurements of core body temperature (nasopharyngeal) with non-invasive oral and forehead temperature monitoring using the SpotOn system
Measured: From study start to up to 60 days from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Nov 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: recruitment was not feasible due to COVID-19 pandemic so study was stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- The participants will receive CRRT in the form of CVVH or CVVHDF using the PrisMaxTM dialysis machine (Baxter Healthcare Corporation) according to local standard operating procedures. Filter anticoagulation will be maintained using either no anticoagulation, regional citrate or heparin. The TherMax™ blood warmer will be used when required to maintain a minimum body temperature. All participants will undergo CRRT via a temporary double-lumen hemodialysis catheter inserted into a central vein (internal jugular vein, subclavian vein, femoral vein). The standard of care entails continuous dialysis therapy for as long as deemed clinically necessary by the doctor. An external heater is used to rewarm the blood before delivering it back to the patient. If assigned to the intervention group, cool blood will be received during continuous dialysis. The cool blood will be delivered by having the heater set to 35.5°C.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marat Slessarev, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Marat Slessarev, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103307
- Sponsor's protocol ID
- 113951
- Status last verified
- Mar 2024
- First submitted
- 9 Aug 2019
- Last updated
- 13 Mar 2024
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Patients Receiving Continuous Renal Replacement Therapy for Acute Kidney Injury by Cooling Blood in the Dialysis Circuit (CRRiTiCool): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04103307
- Acronym / sponsor ID
- 113951
- Keywords
- Cooling, CRRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: recruitment was not feasible due to COVID-19 pandemic so study was stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Sep 2019 (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 injury (AKI) is common in intensive care unit (ICU) patients and is associated with longer hospital stays and worse survival. The mortality rate of critically ill patients in the ICU who receive renal replacement therapy for AKI ranges between 50-80%, cardiovascular disease being the second largest cause of death. A previous pilot study from the investigator's group showed that myocardial stunning occurs in AKI patients during continuous renal replacement therapy (CRRT) and may explain the high cardiovascular mortality in this population. In the chronic intermittent dialysis setting, mild dialysate cooling was shown to improve intradialytic hemodynamic stability and prevent myocardial stunning. The aim of this study is to find out whether cooling the blood in the CRRT circuit is an effective intervention to prevent myocardial stunning in AKI patients undergoing CRRT and improve patient outcomes.
Detailed description
This is a single center, prospective, randomized, open label, controlled trial comparing standard-of-care temperature management with blood cooling CRRT. We will recruit approximately 140 patients (70 in each group) from the Medical Surgical Intensive Care Unit at University Hospital and The Critical Care Trauma Center at Victoria Hospital in London, Ontario.
The study team will randomize patients with acute kidney injury requiring continuous dialysis therapy into one of two groups; either to standard of care continuous dialysis therapy or to cool blood continuous dialysis therapy. All therapy will be delivered using the Baxter PrisMaxTM CRRT machine with TherMaxTM blood warmer.
All participants will undergo a series of echocardiograms (ultrasound of your heart) prior to continuous dialysis therapy initiation, 4-12 hours into therapy, for up to 7 days after therapy initiation, and at discharge from the intensive care unit. Blood work will be collected at 4 time points, prior to continuous dialysis therapy initiation, 4-12 hours into therapy, 24 hours into therapy, and at ICU discharge.
Hourly nasopharyngeal and skin temperatures will be collected. Oral temperature will be collected every four hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants will receive CRRT in the form of CVVH or CVVHDF using the PrisMaxTM dialysis machine (Baxter Healthcare Corporation) according to local standard operating procedures. Filter anticoagulation will be maintained using either no anticoagulation, regional citrate or heparin. The TherMax™ blood warmer will be used when required to maintain a minimum body temperature. All participants will undergo CRRT via a temporary double-lumen hemodialysis catheter inserted into a central vein (internal jugular vein, subclavian vein, femoral vein). The standard of care entails continuous dialysis therapy for as long as deemed clinically necessary by the doctor. An external heater is used to rewarm the blood before delivering it back to the patient. If assigned to the intervention group, cool blood will be received during continuous dialysis. The cool blood will be delivered by having the heater set to 35.5°C.
| Arm | Type | Receives |
|---|---|---|
| Control: Standard of care | No intervention | –Participants in the control group will receive standard-of-care CRRT prescriptions, and have the returning venous blood warmed with an external blood warmer to a temperature of 37°C. The blood warmer temperature will be adjusted by the CRRT nurse as per usual practice to maintain normothermia. |
| Intervention: Cooling | Experimental | Procedure: Dialysis coolingParticipants in the intervention group will receive standard of care CRRT prescriptions and have the blood warmer set to 35.5°C, as long as the nasopharyngeal temperature remains above 35.5°C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AKI as defined by 2012 AKI KDIGO guidelines requiring CRRT.
- Patient's core temperature between 35°C and 40°C at the time of recruitment.
- Age 18 years old and older.
Key exclusion criteria (6 listed)
- Hypothermia (patient core temperature <35°C) at the time of recruitment
- Extreme hyperthermia or hyperpyrexia (patient core temperature >40°C) at the time of recruitment.
- Contraindication to cooling (e.g., hemorrhagic shock or severe coagulopathy)
- Patients undergoing targeted temperature management for cardiac arrest.
- Chronic kidney disease stage 5 as defined by CKD KDIGO guidelines [19] requiring renal replacement therapy prior to recruitment.
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 |
|---|---|---|
| Dialysis coolingCooling the blood in the CRRT circuit during delivery | Procedure or surgery | Intervention: Cooling |
Primary outcome
Regional Wall Motion Abnormalities
Time frame: At the end of delivery of cool blood during continuous dialysis; 12 to 24 hours
Number of segments undergoing a 20% reduction in longitudinal systolic strain
16 secondary outcomes
Regional Wall Motion Abnormalities at 7 days
Time frame: Seven days after the start of cool blood delivery during continuous dialysis
Regional Wall Motion Abnormalities at ICU discharge
Time frame: At ICU discharge, an average of 60 days after the start of cool blood delivery during continuous dialysis
Duration of Continuous Renal Replacement Therapy (CRRT)
Time frame: Through study completion, an average of 60 days
Renal Recovery at 7 days after cool blood continuous dialysis requiring acute kidney injury
Time frame: Seven days after the start of cool blood delivery during continuous dialysis
Renal Recovery at 24 hours after cool blood continuous dialysis requiring acute kidney injury
Time frame: 24 hours after the start of cool blood delivery during continuous dialysis
Low blood pressure
Time frame: Through study completion, an average of 60 days
Cumulative vasopressor dose
Time frame: Through study completion, an average of 60 days
Patient's Core Body Temperature (Celsius degrees)
Time frame: Through study completion, an average of 60 days
Temperature of venous blood in return line (Celsius degrees)
Time frame: Through study completion, an average of 60 days
Intensive care unit free days
Time frame: After an average of 60 days in the ICU
ICU length of stay
Time frame: Through study completion, an average of 60 days
Hospital length of stay
Time frame: Through study completion, an average of 60 days to hospital discharge
ICU mortality
Time frame: Through study completion, an average of 60 days
In Hospital Mortality
Time frame: Through study completion, an average of 60 days to hospital discharge
60-day Mortality
Time frame: From study start to up to 60 days from study start
Temperature correlation between nasopharyngeal, forehead, and oral temperature measurements
Time frame: From study start to up to 60 days from study start
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 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.
Marat Slessarev, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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 Dialysis cooling in people with Acute Kidney Injury and Continuous Renal Replacement Therapy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 13 Mar 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 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Regional Wall Motion Abnormalities (time frame: At the end of delivery of cool blood during continuous dialysis; 12 to 24 hours). 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 13 Mar 2024.