Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT06390592
Eligibility Criteria:
Inclusion Criteria:
* Informed consent signed and dated by study patient and investigator/ authorised physician
* Minimum age of 18 years
* CKD patients with indication for renal replacement therapy
* Patients being treated with APD for at least 3 months
* Patients using the sleep•safe harmony PD cycler (version 3.1)
* Fluid status regularly monitored with Body Composition Monitor (BCM)
* Proper functioning catheter
* Intraperitoneal Pressure (IPP) ≤ 18 cm H2O
* Ability to understand the nature and requirements of the study
Exclusion Criteria:
* Any conditions which could interference with the patient's ability to comply with the study
* Previous participation in the same study
* Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
* Patients receiving polyglucose containing PD solution
* Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation
* Patients who suffer from peritonitis/exit site infection during the last 4 weeks
* Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
* Life expectancy \<3 months
* Participation in an interventional clinical study during the preceding 90 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06390592
Study Brief:
Protocol Section:
NCT06390592