Trial · NCT03046758
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Main trial (14 patients): Drop of white blood cell counts | 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. |
| Primary | Sub-trial (8 patients): The pharmacokinetics of fosfomycin. | 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. |
| Secondary | Main trial (14 patients): Biochemical markers | 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. |
| Secondary | Main trial (14 patients): Blood pressure | 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). |
| Secondary | Main trial (14 patients): Pulse | 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). |
| Secondary | Main trial (14 patients): Frequency of respiration | 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). |
| Secondary | Main trial (14 patients): Peripheral saturation | 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). |
| Secondary | Main trial (14 patients): Temperature | 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). |
| Secondary | Main trial (14 patients): Length of stay. | 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). |
| Secondary | Main trial (14 patients): Length of stay. | Until 30 days postoperatively. | Length of stay in hours postoperatively (minimum 12 hours). |
| Secondary | Main trial (14 patients): Side effects | 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. |
| Secondary | Main trial (14 patients): Adverse events | 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. |
| Secondary | Sub-trial (8 patients): The pharmacokinetics of metronidazole. | 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. |
| Secondary | Sub-trial (8 patients): Microbiological flora and susceptibility | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03046758/registered