The Aim of This Investigation is to Compare the Influence of 0.9% Saline and Plasmalyte Solution on Acid-base Balance and Electrolytes in Healthy Patients Undergoing Major Spine Surgeries.
1 other identifier
interventional
50
1 country
1
Brief Summary
Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance and metabolic acidosis in critically ill patients. The aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major spine surgeries.
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 2012
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 7, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2013
CompletedMay 16, 2013
May 1, 2013
10 months
May 7, 2013
May 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
base-excess
Change from baseline in base-excess at postoperative 12 h
Study Arms (2)
0.9% saline
EXPERIMENTALIn each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
plasmalyte
ACTIVE COMPARATORIn each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
Interventions
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
Eligibility Criteria
You may qualify if:
- patients (aged 20-65) undergoing cervical or lumbar spine surgery who were diagnosed spinal stenosis involving more than tow spinal levels.
You may not qualify if:
- ASA class III or IV
- pregnancy
- breast feeding
- lack of mental weakness(including disabled)
- using diuretics
- respiratory insufficiency
- metabolic acidosis or alkalosis
- coagulation disorder
- over hydtration
- renal failure or serum creatinine \> 1.4mg/dl
- anemia (Hemoglobin 9.0\<mg/dl)
- hypernatremia (Na \> 145mEq/L)
- Hyperkalemia (K\>5.5mEq/L)
- psychological medication or any drugs that influences renal clearance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Seoul, 120-752, South Korea
Related Publications (1)
Song JW, Shim JK, Kim NY, Jang J, Kwak YL. The effect of 0.9% saline versus plasmalyte on coagulation in patients undergoing lumbar spinal surgery; a randomized controlled trial. Int J Surg. 2015 Aug;20:128-34. doi: 10.1016/j.ijsu.2015.06.065. Epub 2015 Jun 27.
PMID: 26123384DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2013
First Posted
May 16, 2013
Study Start
March 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
May 16, 2013
Record last verified: 2013-05