RL Versus Glucose Saline in Cancer Patient Undergoing Major Surgeries and Its Impact on Electrolytes, GLC & pH

NCT05810662 | Unknown

• 1 other identifier: AP1907-30106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare two electrolytes maintenance in perioperative period in children undergoing major surgeries on perioperative change in pH,lactate,sodium and glucose level

Conditions

Fluid and Electrolyte Imbalance

Outcome Measures

Primary Outcomes (1)

• PH and lactate level

  Three ABG will be collected from the patient. The first at start before any intervention,the second after start of replacement and the third at the end of the operation.

  In the introperative period

Secondary Outcomes (1)

• Sodium and glucose level

  The intraoperative period

Study Arms (2)

Ringer lactate

ACTIVE COMPARATOR

Ringer's lactate solution, or lactated Ringer's solution, is a type of isotonic, crystalloid fluid further classified as a balanced or buffered solution used for fluid replacement. The contents of Ringer's lactate include sodium, chloride, potassium, calcium, and lactate in the form of sodium lactate, mixed into a solution with an osmolarity of 273 mOsm/L and pH of about 6.5.

Other: Lactated ringer and dextrose 5%

5%dextrose in 0.9%saline

ACTIVE COMPARATOR

5% Dextrose and 0.45% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a large volume parenteral solution containing dextrose and sodium chloride in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains dextrose, hydrous 5 g and sodium chloride 0.45 g in water for injection. Electrolytes per 1000 mL: sodium (Na+), 77 mEq; chloride (Cl-) 77 mEq. The osmolarity is 406 mOsmol/L (calc.), which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3 (3.5 to 6.5). 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection.

Other: Lactated ringer and dextrose 5%

Interventions

Lactated ringer and dextrose 5% OTHER

Fluid use perioperative

5%dextrose in 0.9%saline; Ringer lactate

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 10 years Children undergoing major surgeries ie considered major if any invasive procedure in which extensive resection will be preformed e.g body cavity is opened,organs are removed and normal anatomy is altered abd duration not less than 2 hours or more than 5 hours.

You may not qualify if:

• patient guardian refusal
• \_ Children with documented endocrine distrubances(DM,inborn error of metabolism,hyperthyroidism)
• age less than one year
• preexisting renal disease,hepatic disease and patien suffering from heart failure.
• preexisting electrolyte imbalance (normal sodium level 135-145)

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer institute

Cairo, Egypt

Location

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia specialist

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 12, 2023
• Study Start: September 4, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Will always be available

Locations

EG (1)