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

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ClinicalTrials.gov Identifier: NCT03054922

Recruitment Status : Enrolling by invitation

First Posted : February 16, 2017

Last Update Posted : February 27, 2018

Sponsor:

Information provided by (Responsible Party):

David P. Martin, Nationwide Children's Hospital

Study Description

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

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	180 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
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Drug Information available for: Normosol R Plasmalyte A PlasmaLyte Plasmalyte 148

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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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.

Contacts and Locations

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


United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Nationwide Children's Hospital

More Information


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:	February 27, 2018
Last Verified:	February 2018
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

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