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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Active Comparator | 0.9% Sodium Chloride |
|
| Lactated Ringers | Active Comparator | 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 |
|
| Normosol-R | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline | Drug | IV infusion of 0.9% NaCl throughout surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Base Deficit | Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis | During surgery (typically 4-6 hrs in length) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sodium | Change in sodium electrolyte from 1st to 2nd blood gas | During surgery (typically 4-6 hrs in length) |
| Change in Potassium | Change in potassium electrolyte from 1st to 2nd blood gas |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | 0.9% Sodium Chloride Normal Saline: IV infusion of 0.9% NaCl throughout surgery. |
| FG001 | Lactated Ringers | 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 Lactated Ringer: IV infusion of lactated ringer throughout surgery. |
| FG002 | Normosol-R | 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. Normosol-R Inj: IV infusion of Normosol throughout surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | 0.9% Sodium Chloride Normal Saline: IV infusion of 0.9% NaCl throughout surgery. |
| BG001 | Lactated Ringers | 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 Lactated Ringer: IV infusion of lactated ringer throughout surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Base Deficit | Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis | Posted | Mean | Standard Deviation | mEq/L | During surgery (typically 4-6 hrs in length) |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline | 0.9% Sodium Chloride Normal Saline: IV infusion of 0.9% NaCl throughout surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David P. Martin, MD | Nationwide Children's Hospital | 614-722-4200 | david.martin@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2017 | Feb 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Lactated Ringer | Drug | IV infusion of lactated ringer throughout surgery. |
|
| Normosol-R Inj | Drug | IV infusion of Normosol throughout surgery. |
|
| During surgery (typically 4-6 hrs in length) |
| Change in Ionized Calcium | Change in calcium electrolyte from 1st to 2nd blood gas | During surgery (typically 4-6 hrs in length) |
| Change in pH | Change in pH from 1st to 2nd blood gas | During surgery (typically 4-6 hrs in length) |
| BG002 | Normosol-R | 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. Normosol-R Inj: IV infusion of Normosol throughout surgery. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kilograms |
|
| OG002 |
| Normosol-R |
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. Normosol-R Inj: IV infusion of Normosol throughout surgery. |
|
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| Secondary | Change in Sodium | Change in sodium electrolyte from 1st to 2nd blood gas | Posted | Mean | Standard Deviation | mEq/L | During surgery (typically 4-6 hrs in length) |
|
|
|
| Secondary | Change in Potassium | Change in potassium electrolyte from 1st to 2nd blood gas | Posted | Mean | Standard Deviation | mEq/L | During surgery (typically 4-6 hrs in length) |
|
|
|
| Secondary | Change in Ionized Calcium | Change in calcium electrolyte from 1st to 2nd blood gas | Posted | Mean | Standard Deviation | mEq/L | During surgery (typically 4-6 hrs in length) |
|
|
|
| Secondary | Change in pH | Change in pH from 1st to 2nd blood gas | Posted | Mean | Standard Deviation | units on a scale | During surgery (typically 4-6 hrs in length) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Lactated Ringers | 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 Lactated Ringer: IV infusion of lactated ringer throughout surgery. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Normosol-R | 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. Normosol-R Inj: IV infusion of Normosol throughout surgery. | 0 | 20 | 0 | 20 | 0 | 20 |
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| Male |
|