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


Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Carcinoma of the Large Intestine

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Trial Information

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


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

Type of Study:

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

Outcome Measure:

acid/base disorder

Outcome Description:

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)

Outcome 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

Safety Issue:

Yes

Principal Investigator

Carlo A Volta, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Ferrara Univesity

Authority:

Italy: The Italian Medicines Agency

Study ID:

HC-I-H-0909

NCT ID:

NCT01320891

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Carcinoma of the Large Intestine
  • general anaesthesia for major abdominal surgery
  • Carcinoma
  • Colorectal Neoplasms

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