Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
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ClinicalTrials.gov Identifier: NCT03054922 |
Recruitment Status :
Completed
First Posted : February 16, 2017
Last Update Posted : January 29, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anesthesia | Drug: Normal Saline Drug: Lactated Ringer Drug: Normosol-R Inj | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables |
Actual Study Start Date : | February 23, 2017 |
Actual Primary Completion Date : | September 30, 2018 |
Actual Study Completion Date : | September 30, 2018 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Normal Saline
0.9% Sodium Chloride
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Drug: Normal Saline
IV infusion of 0.9% NaCl throughout surgery.
Other Name: 0.9% NaCl |
Active Comparator: 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 |
Drug: Lactated Ringer
IV infusion of lactated ringer throughout surgery. |
Active Comparator: 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.
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Drug: Normosol-R Inj
IV infusion of Normosol throughout surgery. |
- Base deficit [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]Obtained from blood gas to measure metabolic acidosis
- Sodium [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]Level of sodium electrolyte in blood
- Potassium [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]Level of potassium electrolyte in blood
- Ionized calcium [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]Level of calcium electrolyte in blood
- Fluid requirement [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]Amount of fluid required for resuscitation during surgery
- Urine output [ Time Frame: End of surgery (typically 4-6 hrs after baseline or start of surgery) ]Amount of urine produced during surgery

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Ages Eligible for Study: | 10 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Major surgical procedure requiring arterial access
Exclusion Criteria:
- Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid solutions.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054922
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 |
Responsible Party: | David P. Martin, Director, Acute Pain Services, Nationwide Children's Hospital |
ClinicalTrials.gov Identifier: | NCT03054922 History of Changes |
Other Study ID Numbers: |
IRB16-01093 |
First Posted: | February 16, 2017 Key Record Dates |
Last Update Posted: | January 29, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
Plasma-lyte 148 Ophthalmic Solutions Pharmaceutical Solutions |