Metabolomics of Intraoperative Saline and Balanced Crystalloid Infusion

Metabolomics Clinical Trial

Official title:

Comparison Between 0.9% Saline and Balanced Crystalloid on Intraoperative Metabolomic Profiles Among Patients Undergoing Major Spine Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04137042
• Other study ID #: 201907091RINA
• Status: Completed
• Phase: N/A
• Start date: March 25, 2020
• Est. completion date: May 3, 2021

Study information

• Verified date: November 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion criteria:

1. age between 40 and 65 year-old

2. major lumbar spine surgery (spinal fusion?multiple levels or expected operation time> 2 hr)

Exclusion criteria:

1. Preoperative organ dysfunction, such as impaired liver function, eg. AST or ALT >100; liver cirrhosis > Child B class; Impaired renal function, eGFR< 60 ml/min/1.73 m2; cardiac dysfunction, such as heart failure > NYHA class II, coronary arterial disease, chronic obstructive pulmonary disease

2. Preoperative use of medications which interfere with liver, renal, glucose or electrolyte metabolism, such as insulin, statin or digoxin

3. Pregnancy

Related Conditions & MeSH terms

• Metabolomics

Intervention

Drug:
• Saline
Intraoperative fluid therapy is administrated by using 0.9% saline
• Balanced crystalloid
Intraoperative fluid therapy is administrated by using balanced crystalloid

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of metabolites in serum and urine measured by metabolomic mass spectrometry	Serum and urine samples will be collected twice (before and immediately after surgery) in each patient.	2-6 hours
Secondary	Intraoperative arterial blood gas profile	Comparison of the arterial blood gas analysis between the two study groups	2-6 hours
Secondary	Intraoperative hemodynamic stability	Comparison of intraoperative norepinephrine requirement between the two study groups	2-6 hours