Clinical Trial: The Safety and Pharmacokinetics of Intraperitoneal Administration in Patients Undergoing Appendectomy for Uncomplicated Appendicitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Safety and Pharmacokinetics of Intraperitoneal Administration of Granulocyte-macrophage Colony-stimulating Factor, Fosfomycin, and Metronidazole in Patients Undergoing Appendectomy for Uncomplicat

Brief Summary: The objective of this trial is to evaluate the safety of the intraperitoneal administration of the combination of fosfomycin, metronidazole, and granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients undergoing surgery for uncomplicated appendicitis. Further, in a sub-trial the aim is to investigate the plasma concentrations of fosfomycin and metronidazole after intraperitoneal administration.

Detailed Summary:
Sponsor: Herlev Hospital

Current Primary Outcome:

  • Main trial (14 patients): Drop of white blood cell counts [ Time Frame: 4 hours (± 30 minutes) ]
    The safety of intraperitoneal administration is evaluated through the white blood cell counts 4 hours (± 30 minutes) postoperatively. A toxic effect is defined by a drop below the lower reference range.
  • Sub-trial (8 patients): The pharmacokinetics of fosfomycin. [ Time Frame: Until 24 hours after surgery ±4 hours. ]
    The plasma concentrations of fosfomycin over time are measured with high-performance liquid chromatography mass spectrometry (HPLC-MS) until 24 hours after surgery ±4 hours.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Main trial (14 patients): Biochemical markers [ Time Frame: 4 hours ±30 minutes postoperatively. ]
    A standard panel of blood samples (e.g. white blood cell differential count, inflammation marker C-reactive protein (CRP), kidney function tests, liver function tests, and electrolytes) are analysed at admission (baseline) and 4 hours ±30 minutes postoperatively, these markers are compared.
  • Main trial (14 patients): Blood pressure [ Time Frame: Until 12 hours ±30 minutes. ]
    Blood pressure in mmHg is measured perioperatively (baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered) and postoperatively (4 and 12 hours ±30 minutes after the trial treatment has been administered).
  • Main trial (14 patients): Pulse [ Time Frame: Until 12 hours ±30 minutes. ]
    Pulse in beats per minute is measured perioperatively (baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered) and postoperatively (4 and 12 hours ±30 minutes after the trial treatment has been administered).
  • Main trial (14 patients): Frequency of respiration [ Time Frame: Until 12 hours ±30 minutes. ]
    Frequency of respiration in breaths per minute is measured perioperatively (baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered) and postoperatively (4 and 12 hours ±30 minutes after the trial treatment has been administered).
  • Main trial (14 patients): Peripheral saturation [ Time Frame: Until 12 hours ±30 minutes. ]
    Peripheral saturation of oxygen in percent is measured perioperatively (baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered) and postoperatively (4 and 12 hours ±30 minutes after the trial treatment has been administered).
  • Main trial (14 patients): Temperature [ Time Frame: Until 12 hours ±30 minutes. ]
    Temperature in degrees Celsius is measured perioperatively (baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered) and postoperatively (4 and 12 hours ±30 minutes after the trial treatment has been administered).
  • Main trial (14 patients): Length of stay. [ Time Frame: Until 30 days postoperatively. ]
    Length of stay in hours postoperatively (minimum length of stay: 12 hours but information on length of stay is collected until 30 days postoperatively).
  • Main trial (14 patients): Length of stay. [ Time Frame: Until 30 days postoperatively. ]
    Length of stay in hours postoperatively (minimum 12 hours).
  • Main trial (14 patients): Side effects [ Time Frame: 10 days postoperatively ±1 day. ]
    Side effects are evaluated through an objective examination and questions about changes 12 hours ±30 minutes and 10 days postoperatively ±1 day.
  • Main trial (14 patients): Adverse events [ Time Frame: Until 30 days postoperatively. ]
    Adverse events are registered from the surgery until 30 days postoperatively through medical records and contact with the participant by telephone.
  • Sub-trial (8 patients): The pharmacokinetics of metronidazole. [ Time Frame: Until 24 hours after surgery ±4 hours. ]
    The plasma concentrations of metronidazole over time are measured with HPLC-MS until 24 hours after surgery ±4 hours.
  • Sub-trial (8 patients): Microbiological flora and susceptibility [ Time Frame: Until 30 days postoperatively. ]
    The microbiological flora and susceptibility of specimens collected during the surgery from the abdominal excess fluid and/or swab from the appendices are investigated.


Original Secondary Outcome: Same as current

Information By: Herlev Hospital

Dates:
Date Received: February 2, 2017
Date Started: February 24, 2017
Date Completion: June 2017
Last Updated: February 24, 2017
Last Verified: February 2017