Bowel Cleansing With Renal Impairment

NCT05349851 | Unknown

• 1 other identifier: 2020/9515
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Colonoscopy; Bowel cleansing; Renal impairment; Hydroelectrolytic adverse effects

Outcome Measures

Primary Outcomes (1)

• Global incidence of renal adverse effects (AEs)

  Global incidence of renal adverse effects (AEs) (yes/no) if any of the following variables have an abnormal value in serum: sodium, potassium, calcium, chloride, bicarbonate, creatinine, or the glomerular filtrate rate calculated with the MDRD formula and the CKD-EPI formula.

  3 hours to 7 days after laxative intake

Secondary Outcomes (21)

• Serum sodium concentration

  3 hours to 7 days after laxative intake

• Serum potasium concentration

  3 hours to 7 days after laxative intake

• Serum ionized calcium concentration

  3 hours to 7 days after laxative intake

• Serum chloride concentration

  3 hours to 7 days after laxative intake

• Serum bicarbonate concentration

  3 hours to 7 days after laxative intake

Study Arms (1)

Renal failure patiens

Patients with advanced renal failure

Other: Follow-up with blood and urine analysis

Interventions

Follow-up with blood and urine analysis OTHER

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.

Renal failure patiens

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment

You may qualify if:

• Outpatients or hospitalized patients with previously scheduled colonoscopy with any indication: screening, follow-up or symptoms.
• Diagnosis of stage 3B-5D chronic renal failure (creatinine clearance less than 45 ml / min / 1.73 m2).

You may not qualify if:

• Age less than 18 years or greater than 80 years
• Partial or total colectomy
• Severe constipation
• Active inflammatory bowel disease
• Severe hepatic impairment (Child Pugh Classification C)
• Pregnancy or breastfeeding
• Refusal to authorize the clinical registration of the information

Sponsors & Collaborators

• Marco Antonio Alvarez Gonzalez: lead
• Complejo Hospitalario de Navarra: collaborator
• Althaia Xarxa Assistencial Universitària de Manresa: collaborator

Study Sites (2)

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Catalonia, 08243, Spain

RECRUITING

Hospital Reina Sofía

Tudela, Navarre, Spain

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Blood Specimen Collection; Urinalysis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• Marco A Álvarez, MD, PhD

  Althaia Xarxa Assistencial Universitària de Manresa; Institut Hospital del Mar d'investigacions mèdiques, Barcelona.

  PRINCIPAL INVESTIGATOR

• Eduardo Albéniz, MD, PhD

  Hospital Universitario de Navarra; Navarrabiomed; UPNA; IdiSNA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco A Álvarez, MD, PhD

CONTACT

0034 933160595; maalvarez@althaia.cat

Eduardo Albéniz, MD, PhD

CONTACT

0034 848420370; ealbenia@navarra.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 27, 2022
• Study Start: October 5, 2021
• Primary Completion: January 31, 2024
• Study Completion: March 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)