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Bowel Cleansing With Renal Impairment

NCT05349851 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 237

Last updated 2023-11-18

No results posted yet for this study

Summary

Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte disturbances and volume overload, especially in patients with advanced renal failure. Polyethylene glycol-based regimens are considered safe, even in patients with advanced renal failure. However, the incidence of adverse effects (AEs) in routine clinical practice is unknown. The main objective of this study is to carry out a prospective, observational, multicenter clinical registry of renal AE of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation. Variables related to kidney function, bowel-cleansing efficacy, and tolerance will also be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis).

Conditions

  • Renal Impairment
  • Adverse Effects of Medical Drugs

Interventions

OTHER

Follow-up with blood and urine analysis

The patients will receive the preparation standards according to the usual clinical practice of each center. On the day of the colonoscopy, patient will be informed about this study and the informed consent will be requested to record the study information. Then, an analysis will be carried out. A second visit will be carried out, follow-up at 3-7 days, which will include a clinical interview and an analysis, being the unique intervention that patients receive.

Sponsors & Collaborators

  • Complejo Hospitalario de Navarra

    collaborator OTHER

  • Althaia Xarxa Assistencial Universitària de Manresa

    collaborator OTHER

  • Marco Antonio Alvarez Gonzalez

    lead OTHER

Principal Investigators

  • Marco A Álvarez, MD, PhD · Althaia Xarxa Assistencial Universitària de Manresa; Institut Hospital del Mar d'investigacions mèdiques, Barcelona.

  • Eduardo Albéniz, MD, PhD · Hospital Universitario de Navarra; Navarrabiomed; UPNA; IdiSNA

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2024-01-31
Completion
2024-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05349851 on ClinicalTrials.gov