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Other research priorities during Covid-19 pandemic.
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| Name | Class |
|---|---|
| Danderyd Hospital | OTHER |
| Stockholm South General Hospital | OTHER |
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A randomized controlled clinical trial. 24 adult ICU patients will be recruited upon decision to administer fluid bolus of 500ml of crystalloid. The fluid will then be randomized to be infused at controlled room temperature or warmed to body temperature. Hemodynamic measurements will be made for 2 hours following the bolus, and laboratory values will be noted. The hypothesis is that part of the hemodynamic response will differed in response to cooling, and be larger in the cold group.
A randomized controlled clinical trial of the influence of fluid temperature on hemodynamic effects of fluids. 24 adult ICU patients meeting objective criteria of circulatory impairment (hypotension, tachycardia, lactatemia etc) will be recruited upon decision to administer fluid bolus of 500ml of crystalloid. The fluid will then be randomized to be infused at controlled room temperature of 22 degrees or warmed to body temperature at 38 degrees. All patients will be monitored with either calibrated or uncalibrated pulse contour analysis. Hemodynamic measurements (Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), Cardiac output (CO), Cardiac index (CI), Stroke volume (SV), Stroke volume variation (SVV), Extravascular lung water (EVLW) etc) will be registered for 2 hours following the bolus, and laboratory values such as lactate, creatinine will be noted, as well as fluid balances. Confounders such as levels of vasopressors, sedation, switches in positioning och or ventilation will be registered. The hypothesis is that part of the hemodynamic response will differed in response to cooling, and be larger in the cold group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Body temperature fluid bolus of crystalloid | Active Comparator | Fluid bolus at 38 degrees celsius of 500ml crystalloid over 15 minutes |
|
| Room temperature fluid bolus of crystalloid | Experimental | Fluid bolus at 22 degrees celsius of 500ml crystalloid over 15 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body temperature | Other | Warming of administered fluid bolus |
| |
| Measure | Description | Time Frame |
|---|---|---|
| MAP | Mean arterial pressure | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| MAP | Systolic blood pressure | 1 hour |
| MAP | Systolic blood pressure | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Cronhjort, MD, PhD | maria.cronhjort@ki.se | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Stockholm | 118 83 | Sweden | |||
| Danderyds sjukhus |
No data will be shared outside the research group
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D018805 | Sepsis |
| D004487 | Edema |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001831 | Body Temperature |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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RCT, unblinded
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Investigators will be blinded during analysis but unblinded during study performance.
| Fluid bolus |
| Drug |
Administration of fluid bolus of crystalloid of 500ml over 15 minutes |
|
| Room temperature | Other | Cooling of administered fluid bolus |
|
| SBP |
Systolic blood pressure |
| 15 minutes |
| SBP | Systolic blood pressure | 1 hour |
| SBP | Systolic blood pressure | 2 hours |
| DBP | Diastolic blood pressure | 15 minutes |
| DBP | Diastolic blood pressure | 1 hour |
| DBP | Diastolic blood pressure | 2 hours |
| HR | Heart rate | 15 minutes |
| HR | Heart rate | 1 hour |
| HR | Heart rate | 2 hours |
| CO | Cardiac output | 15 minutes |
| CO | Cardiac output | 1 hour |
| CO | Cardiac output | 2 hours |
| CI | Cardiac index | 15 minutes |
| CI | Cardiac index | 1 hour |
| CI | Cardiac index | 2 hours |
| SV | Stroke volume | 15 minutes |
| SV | Stroke volume | 1 hour |
| SV | Stroke volume | 2 hours |
| SVV | Stroke volume variation | 15 minutes |
| SVV | Stroke volume variation | 1 hour |
| SVV | Stroke volume variation | 2 hours |
| EVLW | Extra vascular lung water | 15 minutes |
| EVLW | Extra vascular lung water | 1 hour |
| EVLW | Extra vascular lung water | 2 hours |
| Type ofh eart rhythm | Heart rhythm | 15 minutes |
| Type of heart rhythm | Heart rhythm | 1 hour |
| Type of heart rhythm | Heart rhythm | 2 hours |
| Levels of administered vasopressors | Amount of pressors | 15 minutes |
| Levels of administered vasopressors | Amount of pressors | 1 hours |
| Levels of administered vasopressors | Amount of pressors | 2 hours |
| Levels of administered sedating medications | Amount of sedation | 15 minutes |
| Levels of administered sedating medications | Amount of sedation | 1 hours |
| Levels of administered sedating medications | Amount of sedation | 2 hours |
| Lactate | Lactate | 15 minutes |
| Levels of lactate | Lactate | 1 hour |
| Levels of lactate | Lactate | 2 hours |
| Hourly urine output | Urine output | 1 hour |
| Hourly urine output | Urine output | 2 hours |
| Temperature change | Temperature change | 15 minutes |
| Temperature change | Temperature change | 1 hour |
| Temperature change | Temperature change | 2 hours |
| Daily fluid balance | Fluid balance | 24 hours |
| Daily fluid balance | Fluid balance | 48 hours |
| Stockholm |
| 182 57 |
| Sweden |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D012816 | Signs and Symptoms |
| D010829 |
| Physiological Phenomena |