Effects of a continuous application of fluids enriched with phosphate on the patients' proper balance of acids and bases during surgery.

Phase 1

• Conditions: This study aims to investigate a new crystalloid fluid therapy regime for the perioperative setting providing stable fluid and acid-base homeostasis in the patient.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2010-024225-20-DE
• Lead Sponsor: niversity Hospital Munich, Germany

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-04
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• only female patients who have given their informed consent
• ASA I-III classified female patients, who are scheduled for an extended abdominal surgical procedure under general anesthesia with routinely planned placement of a central venous and arterial catheter
• age = 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•participation in another clinical trial
•patients who are not personally able to giver their informed consent
•patients at a childbearing age without using contraceptives
• acute or chronic renal failiure (glomerular filtration rate <60ml/min)
• patients suffering from acid-base-dysregulation (i.e. severe acidosis, sepsis, SIRS)
• pregnancy or lactation period (pregnancy testing will be executed on the ward at least one day prior to the surgical procedure)
• edema, hypertonic dehydratation, hyperhidratation
• hyperphosphatemia, hypernatremia,hypocalcemia
• known hypersensitivity against IMPs and/or other components
• known history or active abuse of alcohol and/or drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified