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| Name | Class |
|---|---|
| Skane University Hospital | OTHER |
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The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during continuous renal replacement therapy as compared to the Prismaflo IIS blood warmer used for the PrismaFlex system.
Blood warming devices during continuous renal replacement therapy (CRRT) have not been adequately tested.
The novel TherMax blood warmer for the newly introduced PrisMax System heats blood and replacement solutions via a dry heat plate system. In contrast, the PRISMAFLO IIS Blood Warmer for PRISMAFLEX System uses an electric heating sleeve on a standard CRRT filter set.
Data on adverse events (AE) during continuous renal replacement therapy (CRRT) has been studied and one of the most common AE was hypothermia, reported in 44% of all cases.
The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during CRRT as compared to the blood warmer used for the PrismaFlex system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prior to Thermax Warming | Active Comparator | Baseline temperature |
|
| During warming | Active Comparator | Temperature during Thermax warming |
|
| Post warming | Active Comparator | Temperature after cessation of Thermax warming |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermax Blood Warmer | Device | Patients will be their own controls: Prior to-, during-, and after Thermax blood warming. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Temperature, accuracy | During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature, differences | Difference to 36.5 Celsius, std deviation, interquartile range: Prior to Thermax, during Thermax and after Thermax | 12-18 hours (six hour warming period) |
| Historic comparator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Max Bell, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Marcus Broman, MD, PhD | Skane University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
De-identified patient and machine data may be made available after study completion, but this depends on the patent holder.
Six months after study completion
Data access will be reviewed by the PI:s and research group.
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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The investigators will assess body temperature before-, during- and after Thermax blood warming treatment. Patients are essentially their own controls.
Moreover, we will use historic data on the previous blood warmer for the Prismaflex device to assess temperature changes.
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Using registry/PDMS data, how did the old blood warmer perform with regards to temperature
| 24 hours |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |