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.

May 13, 2013 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1.50 patients (aged 20-65) undergoing cervical or lumbar spine surgery who were diagnosed spinal stenosis involving more than tow spinal levels.

Exclusion Criteria:

  1. ASA class III or IV
  2. pregnancy
  3. breast feeding
  4. lack of mental weakness(including disabled)
  5. using diuretics
  6. respiratory insufficiency
  7. metabolic acidosis or alkalosis
  8. coagulation disorder
  9. over hydtration
  10. renal failure or serum creatinine > 1.4mg/dl
  11. anemia (Hemoglobin 9.0<mg/dl)
  12. hypernatremia (Na > 145mEq/L)
  13. Hyperkalemia (K>5.5mEq/L)
  14. psychological medication or any drugs that influences renal clearance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 0.9% saline
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
Other: 0.9% normal saline
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
ACTIVE_COMPARATOR: plasmalyte
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
Other: plasmalyte
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
base-excess
Time Frame: Change from baseline in base-excess at postoperative 12 h
Change from baseline in base-excess at postoperative 12 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (ESTIMATE)

May 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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