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

This study has been completed.
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by (Responsible Party):
Carlo Alberto Volta, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01320891
First received: March 8, 2011
Last updated: May 3, 2017
Last verified: May 2017
March 8, 2011
May 3, 2017
February 2010
August 2011   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01320891 on ClinicalTrials.gov Archive Site
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)
Same as current
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Not Provided
 
Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators
Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Large Bowel Cancer
  • 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
  • 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
  • Experimental: balanced
    arm in which the subjects received only balanced solutions
    Intervention: Behavioral: balanced solutions
  • Experimental: not balanced
    arm in which the subjects received only not balanced solutions that means only normal saline and colloid dissolved in normal saline
    Intervention: Behavioral: not balanced
Volta CA, Trentini A, Farabegoli L, Manfrinato MC, Alvisi V, Dallocchio F, Marangoni E, Alvisi R, Bellini T. Effects of two different strategies of fluid administration on inflammatory mediators, plasma electrolytes and acid/base disorders in patients undergoing major abdominal surgery: a randomized double blind study. J Inflamm (Lond). 2013 Sep 24;10(1):29. doi: 10.1186/1476-9255-10-29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2012
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01320891
HC-I-H-0909
Yes
Not Provided
Not Provided
Not Provided
Carlo Alberto Volta, Università degli Studi di Ferrara
Università degli Studi di Ferrara
B. Braun Melsungen AG
Study Chair: Carlo A Volta, Professor Ferrara Univesity
Università degli Studi di Ferrara
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP