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
  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 Phase
Carcinoma of the Large Intestine
Behavioral: balanced solutions
Behavioral: not balanced
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ 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)


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 ] [ 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)


Estimated Enrollment: 40
Study Start Date: February 2010
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320891

Contacts
Contact: Carlo A Volta, Professor 0532237005 ext 0039 vlc@unife.it
Contact: Lucia Farabegoli, MD 0532237007 ext 0039 farabegolilucia@gmail.com

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

No publications provided

Responsible Party: Prof. Carlo Alberto Volta, Ferrara University
ClinicalTrials.gov Identifier: NCT01320891     History of Changes
Other Study ID Numbers: HC-I-H-0909
Study First Received: March 8, 2011
Last Updated: March 22, 2011
Health Authority: Italy: The Italian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Università degli Studi di Ferrara:
general anaesthesia for major abdominal surgery

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014