A Phase 3 interventional study of Normal Saline and Lactated Ringer in Anesthesia, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged 10 Years to 21 Years. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by Nationwide Children's Hospital · Phase 3, Interventional, and Treatment
During major surgical procedures, intravascular volume is maintained with the administration of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three of these fluids are in common clinical use for this purpose. As large volumes of NS may result in a dilutional acidosis and an increasing base deficit, it may cloud clinical decision making when resuscitative efforts are guided by acid-base status on routine arterial blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids for intraoperative resuscitation.
Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.9% Sodium Chloride
Drug: Normal Saline
Each 100 mL of Lactated Ringer's Injection USP contains: Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs
Drug: Lactated Ringer
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.
Drug: Normosol-R Inj
IV infusion of 0.9% NaCl throughout surgery.
Also known as: 0.9% NaCl
IV infusion of lactated ringer throughout surgery.
IV infusion of Normosol throughout surgery.
Change in Base Deficit
Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis
Time frame: During surgery (typically 4-6 hrs in length)
Change in Sodium
Change in sodium electrolyte from 1st to 2nd blood gas
Time frame: During surgery (typically 4-6 hrs in length)
Change in Potassium
Change in potassium electrolyte from 1st to 2nd blood gas
Time frame: During surgery (typically 4-6 hrs in length)
Change in Ionized Calcium
Change in calcium electrolyte from 1st to 2nd blood gas
Time frame: During surgery (typically 4-6 hrs in length)
Change in pH
Change in pH from 1st to 2nd blood gas
Time frame: During surgery (typically 4-6 hrs in length)
| Milestone | Normal Saline | Lactated Ringers | Normosol-R |
|---|---|---|---|
| Started | 20 | 19 | 20 |
| Completed | 20 | 19 | 20 |
| Not completed | 0 | 0 | 0 |
Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis
| mEq/L | Normal Saline | Lactated Ringers | Normosol-R |
|---|---|---|---|
| Change in Base Deficit | -1.5 ± 2.4 | -1.2 ± 2.3 | -0.5 ± 1.5 |
Change in sodium electrolyte from 1st to 2nd blood gas
| mEq/L | Normal Saline | Lactated Ringers | Normosol-R |
|---|---|---|---|
| Change in Sodium | 0.1 ± 1.7 | -0.4 ± 1.5 | -0.1 ± 1.9 |
Change in potassium electrolyte from 1st to 2nd blood gas
| mEq/L | Normal Saline | Lactated Ringers | Normosol-R |
|---|---|---|---|
| Change in Potassium | 0.4 ± 0.4 | 0.7 ± 0.6 | 0.2 ± 0.4 |
Change in calcium electrolyte from 1st to 2nd blood gas
| mEq/L | Normal Saline | Lactated Ringers | Normosol-R |
|---|---|---|---|
| Change in Ionized Calcium | 0.01 ± 0.05 | -0.13 ± 0.57 | -0.01 ± 0.08 |
Change in pH from 1st to 2nd blood gas
| units on a scale | Normal Saline | Lactated Ringers | Normosol-R |
|---|---|---|---|
| Change in pH | -0.03 ± 0.04 | -0.02 ± 0.06 | 0.01 ± 0.06 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Normal Saline | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Lactated Ringers | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Normosol-R | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Normal Saline | Lactated Ringers | Normosol-R | Total |
|---|---|---|---|---|
| Mean | 14 ± 3 | 14 ± 2 | 14 ± 2 | 14 ± 2 |
| Sex: Female, Male(Participants) | Normal Saline | Lactated Ringers | Normosol-R | Total |
|---|---|---|---|---|
| Female | 17 | 10 | 14 | 41 |
| Male | 3 | 9 | 6 | 18 |
| Race and Ethnicity Not Collected(Participants) | Normal Saline | Lactated Ringers | Normosol-R | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Normal Saline | Lactated Ringers | Normosol-R | Total |
|---|---|---|---|---|
| United States | 20 | 19 | 20 | 59 |
| Weight(kilograms) | Normal Saline | Lactated Ringers | Normosol-R | Total |
|---|---|---|---|---|
| Mean | 61 ± 13 | 57 ± 19 | 57 ± 18 | 58 ± 17 |
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Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Nationwide Children's Hospital