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Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054922
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
David P. Martin, Nationwide Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Normal Saline Drug: Lactated Ringer Drug: Normosol-R Inj Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Active Comparator: Normal Saline
0.9% Sodium Chloride
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.
Drug: Normosol-R Inj
IV infusion of Normosol throughout surgery.




Primary Outcome Measures :
  1. Change in Base Deficit [ Time Frame: During surgery (typically 4-6 hrs in length) ]
    Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis


Secondary Outcome Measures :
  1. Change in Sodium [ Time Frame: During surgery (typically 4-6 hrs in length) ]
    Change in sodium electrolyte from 1st to 2nd blood gas

  2. Change in Potassium [ Time Frame: During surgery (typically 4-6 hrs in length) ]
    Change in potassium electrolyte from 1st to 2nd blood gas

  3. Change in Ionized Calcium [ Time Frame: During surgery (typically 4-6 hrs in length) ]
    Change in calcium electrolyte from 1st to 2nd blood gas

  4. Change in pH [ Time Frame: During surgery (typically 4-6 hrs in length) ]
    Change in pH from 1st to 2nd blood gas



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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  Study Documents (Full-Text)

Documents provided by David P. Martin, Nationwide Children's Hospital:
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Responsible Party: David P. Martin, Director, Acute Pain Services, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03054922    
Other Study ID Numbers: IRB16-01093
First Posted: February 16, 2017    Key Record Dates
Results First Posted: March 25, 2020
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions