Metabolomics of Intraoperative Saline and Balanced Crystalloid Infusion

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04137042

Collaborator

(none)

Enrollment

Location

Arms

13.3

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolomics	Drug: Saline Drug: Balanced crystalloid	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

comparison between two intraoperative iv. fluidscomparison between two intraoperative iv. fluids

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 25, 2020

Actual Primary Completion Date :

May 3, 2021

Actual Study Completion Date :

May 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Saline intraoperative fluid therapy by using 0.9% saline	Drug: Saline Intraoperative fluid therapy is administrated by using 0.9% saline
Experimental: Balanced crystalloid intraoperative fluid therapy by using balanced crystalloid	Drug: Balanced crystalloid Intraoperative fluid therapy is administrated by using balanced crystalloid

Arm

Intervention/Treatment

Active Comparator: Saline

intraoperative fluid therapy by using 0.9% saline

Drug: Saline

Intraoperative fluid therapy is administrated by using 0.9% saline

Experimental: Balanced crystalloid

intraoperative fluid therapy by using balanced crystalloid

Drug: Balanced crystalloid

Intraoperative fluid therapy is administrated by using balanced crystalloid

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

age between 40 and 65 year-old
major lumbar spine surgery (spinal fusion、multiple levels or expected operation time> 2 hr)

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator: Chun-Yu Wu, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT04137042

Other Study ID Numbers:

201907091RINA

First Posted:

Oct 23, 2019

Last Update Posted:

Jul 19, 2022

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

Metabolomics

Fluid therapy

Study Results

No Results Posted as of Jul 19, 2022