Metabolomics of Intraoperative Saline and Balanced Crystalloid Infusion
Comparison Between 0.9% Saline and Balanced Crystalloid on Intraoperative Metabolomic Profiles Among Patients Undergoing Major Spine Surgery: a Randomized Controlled Trial
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedStudy Start
First participant enrolled
March 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2021
CompletedJuly 19, 2022
November 1, 2020
1.1 years
October 4, 2019
July 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Intraoperative arterial blood gas profile
2-6 hours
Intraoperative hemodynamic stability
2-6 hours
Study Arms (2)
Saline
ACTIVE COMPARATORintraoperative fluid therapy by using 0.9% saline
Balanced crystalloid
EXPERIMENTALintraoperative fluid therapy by using balanced crystalloid
Interventions
Intraoperative fluid therapy is administrated by using balanced crystalloid
Eligibility Criteria
You may qualify if:
- age between 40 and 65 year-old
- major lumbar spine surgery (spinal fusion、multiple levels or expected operation time\> 2 hr)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chun-Yu Wu
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2019
First Posted
October 23, 2019
Study Start
March 25, 2020
Primary Completion
May 3, 2021
Study Completion
May 3, 2021
Last Updated
July 19, 2022
Record last verified: 2020-11