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Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320891
First Posted: March 23, 2011
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
B. Braun Melsungen AG
Information provided by (Responsible Party):
Carlo Alberto Volta, Università degli Studi di Ferrara
  Purpose
Aim of the study is to ascertain whether a different strategy of fluids administration can be responsible of differences in terms of acid/base disorders (Stewart approach), pro-inflammatory and inflammatory mediators. Hence two groups of patients will be treated either with not-balanced solutions (Normal Saline) or balanced solutions

Condition Intervention
Large Bowel Cancer Behavioral: balanced solutions Behavioral: not balanced

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators

Further study details as provided by Carlo Alberto Volta, Università degli Studi di Ferrara:

Primary Outcome Measures:
  • acid/base disorder [ Time Frame: T0: anaesthesia induction (control value) T1: end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery ]
    the investigators assess difference in acid base disorders between the two groups measuring emogas analyses data and blood electrolites levels at the same time (two days)


Secondary Outcome Measures:
  • pro/antiinflammatory cytokine [ Time Frame: T0: anaesthesia induction (control value) T1:end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery ]
    -MMP-9 total and active, TIMP-1, IL-6, IL-8, IL-10, mieloperossidasis, ROS, MCP-3 will be measured during the observation period. (two days)


Enrollment: 40
Actual Study Start Date: February 2010
Study Completion Date: February 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: balanced
arm in which the subjects received only balanced solutions
Behavioral: balanced solutions
during the general anaesthesia until 8 o'clock of the day after the operation the subject will receive only balanced fluids that means balanced crystalloid and colloids dissolved in balanced solution. 12 ml /Kg/h during operation time. ratio 3:1 between crystalloid and colloid.
Other Name: sterofundin, tetraspan
Experimental: not balanced
arm in which the subjects received only not balanced solutions that means only normal saline and colloid dissolved in normal saline
Behavioral: not balanced
during the operation time until the 8 o'clock of the day after the operation, the subjects will receive only normal saline and colloid dissolved in normal saline.
Other Name: Normal saline, Amidolite

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diagnosis of large bowel cancer
  • Age > 18 years old

Exclusion Criteria:

Emergency surgery for bowel punch or intestinal occlusion

  • Massive bleeding
  • Therapy with corticosteroid or nonsteroid antiinflammatory substances
  • Renal insufficiency (serum creatinine > 200 micromol /l)
  • Cardiac insufficiency (NYHA III-IV)
  • Altered liver function (ALT > 40 U/l AST >40 U/l)
  • Preoperative anaemia ( Hb < 10 g/dl )
  • Allergy to hydrossietilic starches
  • Patient rejection to share the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320891


Locations
Italy
S.Anna Universitary Hospital
Ferrara, Italy, 44100
Sponsors and Collaborators
Università degli Studi di Ferrara
B. Braun Melsungen AG
Investigators
Study Chair: Carlo A Volta, Professor Ferrara Univesity
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlo Alberto Volta, Professor, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT01320891     History of Changes
Other Study ID Numbers: HC-I-H-0909
First Submitted: March 8, 2011
First Posted: March 23, 2011
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by Carlo Alberto Volta, Università degli Studi di Ferrara:
general anaesthesia for major abdominal surgery

Additional relevant MeSH terms:
Pharmaceutical Solutions