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NCT Number: NCT04137042

Metabolomics of Intraoperative Saline and Balanced Crystalloid Infusion

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.

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Drug

Intraoperative fluid therapy is administrated by using 0.9% saline

balanced crystalloid

Drug

Intraoperative fluid therapy is administrated by using balanced crystalloid

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intraoperative arterial blood gas profile

    Time frame: 2-6 hours

    Comparison of the arterial blood gas analysis between the two study groups

  2. Intraoperative hemodynamic stability

    Time frame: 2-6 hours

    Comparison of intraoperative norepinephrine requirement between the two study groups

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2019
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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