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Prospective, crossover, randomized trial to evaluate plasma compositions after loading dose of sterofundin solution given to healthy volunteer in the resuscitation manner compared with normal saline solution.
10 healthy volunteers were randomly assigned to receive either normal saline or sterofundin for the first solution in dose of 30 mL/kg (max 2 L) over 1 hour. Blood was collected at baseline (T0), at 60 minutes (T1), 120 minutes (T2), and 240 minutes (T4) from baseline. Time to fist void after initiation of fluid and urine volume were also recorded. After wash-out period of at least 1 week, crossover studies were performed with another fluid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSS | Active Comparator | NSS 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour |
|
| Sterofundin | Experimental | Sterofundin solution 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterofundin | Drug | Fluid loading |
| |
| NSS |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum chloride | At 0, 1, 2, and 4 hours from initiation | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum pH | At 0, 1, 2, and 4 hours from initiation | 4 hours |
| Change in serum osmolality | At 0, 1, 2, and 4 hours from initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunthiti Morakul, MD | Ramathibodi Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18313809 | Background | Awad S, Allison SP, Lobo DN. The history of 0.9% saline. Clin Nutr. 2008 Apr;27(2):179-88. doi: 10.1016/j.clnu.2008.01.008. Epub 2008 Mar 3. | |
| 22580944 | Background | Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72. |
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| ID | Term |
|---|---|
| D013398 | Sudden Infant Death |
| ID | Term |
|---|---|
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C052337 | sterofundin |
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| Drug |
Fluid loading |
|
| 4 hours |
| Change in serum SID | At 0, 1, 2, and 4 hours from initiation | 4 hours |
| Time to first void | Time in minutes from initiation of fluid to first urination | Within 24 hours |
| Urine volume | Volume of first urination in ml | Within 24 hours |
| 23073953 | Background | Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356. |
| 14991093 | Background | Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during acute normovolaemic haemodilution. Intensive Care Med. 2004 Jul;30(7):1432-7. doi: 10.1007/s00134-004-2176-x. Epub 2004 Feb 28. |
| D066088 |
| Infant Death |