Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| University of Southern Denmark | OTHER |
| Simon Fougner Hartmanns Family Foundation | UNKNOWN |
| Department of Clinical Biochemistry, Vejle Hospital |
Not provided
Not provided
Not provided
In this single center crossover study the aim is to investigate the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.18 healthy volunteers will be included. Inclusion criteria is; Age between 18-64. Exclusion criteria is; Pre-existing medical problems, Pregnancy (validated through a certified pregnancy test), Body mass index >35 kg/m2, Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
Participants will be randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. Fluids will be administered through a peripheral vein. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.
Primary outcome is
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold-Warm | Active Comparator | Trial day 1: Participants receive Ringer's lactate cold (15°C, 59°F), Trial day 2: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F) |
|
| Warm-Cold | Active Comparator | Trial day 1: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F) Trial day 2: Participants receive Ringer's lactate cold (15°C, 59°F), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ringer's Lactate | Drug | On the first trial day healthy volunteers are randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures. |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in MAP at 15 minutes after infusion of the fluid bolus. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time until return of MAP to baseline value after infusion. | 2 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39462030 | Derived | Biesenbach P, Molmer MB, Svendsen EL, Teichmann D, Wuthe S, Momeni M, Kristensen MR, Laugesen LE, Berg-Beckhoff G, Bentsen LP, Bergmann ML, Brabrand M. Ringer's lactate administered at 15 degrees C leads to a greater and more prolonged increase in blood pressure compared to 37 degrees C. Sci Rep. 2024 Oct 26;14(1):25592. doi: 10.1038/s41598-024-76858-0. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
|