MetabolomicsNCT04137042
Metabolomics of Intraoperative Saline and Balanced Crystalloid Infusion
A study testing Saline and Balanced crystalloid in people with Metabolomics, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Metabolomics
- What is being tested?
- Saline and Balanced crystalloid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Mar 2020to 3 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 40 and 65 year-old
- major lumbar spine surgery (spinal fusion、multiple levels or expected operation time> 2 hr)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between 0.9% Saline and Balanced Crystalloid on Intraoperative Metabolomic Profiles Among Patients Undergoing Major Spine Surgery: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Metabolomics
- Being tested
- Saline, Balanced crystalloid
- Keywords
- Metabolomics, Fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Intraoperative fluid therapy is administrated by using 0.9% saline
Balanced crystalloidDrug
Intraoperative fluid therapy is administrated by using balanced crystalloid
| Study group | Role | What they receive |
|---|---|---|
| Saline | Active comparator | intraoperative fluid therapy by using 0.9% saline Receives: Drug: Saline |
| Balanced crystalloid | Experimental | intraoperative fluid therapy by using balanced crystalloid Receives: Drug: Balanced crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-6 hours
Secondary outcomes (2)
Intraoperative arterial blood gas profile
Comparison of the arterial blood gas analysis between the two study groups
Measured: 2-6 hours
Intraoperative hemodynamic stability
Comparison of intraoperative norepinephrine requirement between the two study groups
Measured: 2-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start25 Mar 2020
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolomicsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison between two intraoperative iv. fluids
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137042
- Sponsor's protocol ID
- 201907091RINA
- Status last verified
- Nov 2020
- First submitted
- 4 Oct 2019
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 0.9% Saline and Balanced Crystalloid on Intraoperative Metabolomic Profiles Among Patients Undergoing Major Spine Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04137042
- Acronym / sponsor ID
- 201907091RINA
- Conditions
- Metabolomics
- Keywords
- Metabolomics, Fluid therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- comparison between two intraoperative iv. fluids
| Arm | Type | Receives |
|---|---|---|
| Saline | Active comparator | Drug: Salineintraoperative fluid therapy by using 0.9% saline |
| Balanced crystalloid | Experimental | Drug: Balanced crystalloidintraoperative fluid therapy by using balanced crystalloid |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 40 and 65 year-old
- major lumbar spine surgery (spinal fusion、multiple levels or expected operation time> 2 hr)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineIntraoperative fluid therapy is administrated by using 0.9% saline | Drug | Saline |
| Balanced crystalloidIntraoperative fluid therapy is administrated by using balanced crystalloid | Drug | Balanced crystalloid |
Primary outcome
Changes of metabolites in serum and urine measured by metabolomic mass spectrometry
Time frame: 2-6 hours
Serum and urine samples will be collected twice (before and immediately after surgery) in each patient.
2 secondary outcomes
Intraoperative arterial blood gas profile
Time frame: 2-6 hours
Intraoperative hemodynamic stability
Time frame: 2-6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Yu Wu principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline and Balanced crystalloid in people with Metabolomics, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of metabolites in serum and urine measured by metabolomic mass spectrometry (time frame: 2-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.