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OpenTrials
Completed

NCT Number: NCT01320891

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

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Key information

Conditions

Large Bowel Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S.Anna Universitary Hospital

Ferrara, 44100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

balanced solutions

Behavioral

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 names: sterofundin, tetraspan

not balanced

Behavioral

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 names: Normal saline, Amidolite

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Collaborators

  • B. Braun Melsungen AG

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Mar 23, 2011
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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