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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Università degli Studi di Ferrara.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by:
Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01320891
First received: March 8, 2011
Last updated: March 22, 2011
Last verified: March 2011

March 8, 2011
March 22, 2011
February 2010
December 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
-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
Not Provided
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
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carcinoma of the Large Intestine
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
December 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
Both
18 Years to 90 Years
No
Contact: Carlo A Volta, Professor 0532237005 ext 0039 vlc@unife.it
Contact: Lucia Farabegoli, MD 0532237007 ext 0039 farabegolilucia@gmail.com
Italy
 
NCT01320891
HC-I-H-0909
Yes
Prof. Carlo Alberto Volta, Ferrara University
Università degli Studi di Ferrara
B. Braun Melsungen AG
Study Chair: Carlo A Volta, Professor Ferrara Univesity
Università degli Studi di Ferrara
March 2011

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