Bowel Cleansing With Renal Impairment (BC-RIMP)

Clinical Registry of Adverse Effects in the Preparation for Colonoscopy in Patients With Advanced Renal Failure

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).

Study Overview

• Status: Recruiting
• Conditions: Renal Impairment; Adverse Effects of Medical Drugs
• Intervention / Treatment: Other: Follow-up with blood and urine analysis

Detailed Description

Introduction: Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte alterations and volume overload, especially in patients with advanced renal failure. Routine clinical practice of bowel preparation with polyethylene glycol-based regimens, including in patients with advanced renal failure, is considered safe. The hydroelectrolytic AEs and worsening of renal failure are generally mild and transient. However, the incidence of AEs in routine clinical practice is unknown, because there is no prospective record of the incidence of renal AEs in these patients.

Objectives:

1. Principal. To carry out a clinical registry of the renal AEs of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation.

2. Secondary:

   • Study the efficacy of intestinal cleansing using the Boston bowel preparation scale.
   • Study the patient-reported experience measures (PREMs) in terms of tolerability and acceptance of bowel preparation.

Study of the population and sample size: Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment. Ages: 18-80, excluding partial colectomy, severe constipation, active intestinal disease, severe heart or liver failure, pregnancy or lactation, and refusal to authorize the clinical record of information. We calculated a sample size of 237 subjects to show an incidence of renal AD of 10%, with a precision of 4%.

Methods: Identify patients with a scheduled colonoscopy who present advanced renal failure, in the 60 days prior to the colonoscopy. Carry out a prospective, observational, multicenter clinical registry of the routine clinical practice of preparation for colonoscopy. Variables related to renal function, the efficacy of intestinal cleansing, and tolerance will be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis). The data will be collected on the REDCap-AEG online platform, which can be accessed by researchers from each center through an identification code, respecting the current Organic Law on Data Protection.

• Study Type: Observational
• Enrollment (Estimated): 237

Contacts and Locations

• Study Contact: Name: Marco A Álvarez, MD, PhD; Phone Number: 0034 933160595; Email: maalvarez@althaia.cat
• Study Contact Backup: Name: Eduardo Albéniz, MD, PhD; Phone Number: 0034 848420370; Email: ealbenia@navarra.es

Study Locations

• Spain
  • Cataluña
    • Manresa, Cataluña, Spain, 08243
      • Recruiting
      • Althaia Xarxa Assistencial Universitària de Manresa
      • Contact: Raúl Velamazán, MD, PhD
  • Navarra
    • Tudela, Navarra, Spain
      • Recruiting
      • Hospital Reina Sofia
      • Contact: Diego Martínez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Renal failure patiens; Patients with advanced renal failure

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum sodium concentration	Any abnormal value in serum sodium concentration.	3 hours to 7 days after laxative intake
Serum potasium concentration	Any abnormal value in serum potasium concentration.	3 hours to 7 days after laxative intake
Serum ionized calcium concentration	Any abnormal value in serum ionized calcium concentration.	3 hours to 7 days after laxative intake
Serum chloride concentration	Any abnormal value in serum chloride concentration.	3 hours to 7 days after laxative intake
Serum bicarbonate concentration	Any abnormal value in serum bicarbonate concentration.	3 hours to 7 days after laxative intake
Serum creatinine concentration	Any abnormal value in serum creatinine concentration.	3 hours to 7 days after laxative intake
Glomerular filtration rate	Glomerular filtration rate calculated with the MDRD formula and the CKD-EPI formula.	3 hours to 7 days after laxative intake
Serum phosphorus concentration	Any abnormal value in serum phosphorus concentration.	3 hours to 7 days after laxative intake
Serum magnesium concentration	Any abnormal value in serum magnesium concentration.	3 hours to 7 days after laxative intake
Blood pH	Blood pH measurement	3 hours to 7 days after laxative intake
Hemoglobin concentration	Mean corpuscular hemoglobin	3 hours to 7 days after laxative intake
Blood platelets	Number of blood platelets	3 hours to 7 days after laxative intake
Adequate bowel cleansing for colonoscopy	Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing. The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Adequate bowel cleansing will be defined as a BBPS of 2 or more points in every segment of the colon and inadequate bowel cleansing will be defined by at least one of the colon segments with less than 2 points.	At the moment of colonoscopy
Adhrence to laxative intake	Adhrence to laxative intake recorded as >75% of the quantity of laxative intake reported in a questionarie administered with the help of an investigator.	3-5 hours after laxative intake (at the colonoscopy appointment)
Time from last intake of laxative to the colonoscopy	Interval in hours between last intake of laxative and the colonoscopy.	3-5 hours after laxative intake (at the colonoscopy appointment)
Patient-reported experience measures (PREMs) questionnaire of laxative intake	Patient-reported experience measures (PREMs) questionnaire of laxative intake, administered with the help of an investigator. Descriptive subjective scale: Very bad, bad, average, good, very Good.	3-5 hours after laxative intake (at the colonoscopy appointment)
Early side effects of laxative intake	Early side effects of laxative intake. Structured questionnaire nausea, vomiting, dizziness, thirst, headache, abdominal bloating. Non structured for other side effects.	3-5 hours after laxative intake (at the colonoscopy appointment)
Late side effects of laxative intake	Structured questionnaire nausea, vomiting, dizziness, thirst, headache, abdominal bloating, abdominal pain, mental confusion, asthenia, dyspnea, peripheral edema. Non structured for other side effects.	3-7 days after laxative intake
Need of urgent consultation	Number of participants requiring medical consultation for kidney related problems, including emergency room or nephrologist consultation.	3 hours to 7 days after laxative intake
Need for hospital admission	Number of participants requiring hospital admission for any kidney related causes.	3 hours to 7 days after laxative intake
Need of any drug treatment, new treatment or modification, that may affect kidney function or serum electrolytes	Number of participants that require outpatient medication change after the intervention.	3 hours to 7 days after laxative intake

Collaborators and Investigators

• Sponsor: Marco Antonio Alvarez Gonzalez
• Collaborators: Complejo Hospitalario de Navarra; Althaia Xarxa Assistencial Universitària de Manresa
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Colonoscopy; Renal impairment; Bowel cleansing; Hydroelectrolytic adverse effects
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: 2020/9515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No