Metabolomics of Intraoperative Saline and Balanced Crystalloid Infusion

Not Applicable

Completed

• Conditions: Metabolomics
• Interventions: Drug: Saline; Drug: Balanced crystalloid

• Registration Number: NCT04137042
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Different crystalloids, namely 0.9% saline and balanced crystalloid may result in different metabolomic profile among surgical patients. This study aims to investigate the serum and urine profiles between patients undergoing major spine surgery using 0.9% saline and balanced crystalloid.

Detailed Description

Intravenous fluid is mandatory for acute and critically ill patients as well as for surgical patients. Two crystalloid iv. solutions namely 0.9% saline and balanced crystalloid are the most commonly administrated. However, early literature suggests that 0.9% saline is associated with hyperchloremic acidosis, which affects cellular metabolism and may result in worse prognosis among acute or critically ill patients. However, recent literature in 2018, including a meta-analysis and a large randomized controlled trial published in the New England Journal of Medicine revealed neutral or merely slight different clinical outcomes between 0.9% saline and balanced crystalloids. Therefore, the metabolic differences between these two fluids may only exist in specific metabolic pathway which may be easily masked by the complex pathophysiological changes in acute and critically ill patients. These metabolic alteration may be only identified by precise research t the technology such as liquid chromatography mass spectrometry, which provides more comprehensive metabolomics profiles. By comparison, surgical patients undergoing major spine surgery receive a relatively large amount of intravenous infusion during surgery, and there is not complicated with complex pathophysiological alteration of cormorbid diseases. Accordingly, this study aim to identify the metabolomic differences between 0.9% saline and balanced crystalloid among patients undergoing major spine surgery by using the liquid chromatography mass spectrometry technique.

Study Timeline

• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Study Start: 2020-03-25
• Status Verified: 2020-11
• Primary Completion: 2021-05-03
• Study Completion: 2021-05-03
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	intraoperative fluid therapy by using 0.9% saline
Balanced crystalloid	Balanced crystalloid	intraoperative fluid therapy by using balanced crystalloid

Primary Outcome Measures

Name	Time	Method
Changes of metabolites in serum and urine measured by metabolomic mass spectrometry	2-6 hours	Serum and urine samples will be collected twice (before and immediately after surgery) in each patient.

Secondary Outcome Measures

Name	Time	Method
Intraoperative arterial blood gas profile	2-6 hours	Comparison of the arterial blood gas analysis between the two study groups
Intraoperative hemodynamic stability	2-6 hours	Comparison of intraoperative norepinephrine requirement between the two study groups

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan