Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04669964

Evaluating Ileostomy Hydration Protocol

Evaluating the Efficacy of a Standardized Hydration Protocol After Ileostomy Creation

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
The Guthrie Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a prospective observational study on patients who undergo an ileostomy creation after implementing a hydration algorithm as routine care at Robert Packer Hospital. The Department of Surgery will be implementing a protocol to prevent dehydration for patients with high output ileostomies. Patients with high output ileostomies are at an increased risk for readmission for dehydration. By reviewing the data after applying this standardized hydration protocol, we can assess its efficacy on readmission rates and comorbidities stemming from dehydration.

Detailed description

As of January 1, 2021, Robert Packer Hospital will implement a standardized hydration protocol for patients at high risk for readmission due to dehydration. All postoperative ileostomy patients will be provided the following instructions at the bedside to ensure complete comprehension: 1. Stoma maintenance education 2. Hydration recommendations 3. Intake and Output Worksheet education and trial The colorectal surgeons standardized the postoperative medical management of ileostomy output. Before discharge, the healthcare providers will complete a "Discharge Assessment Checklist". On the day of discharge, patients will be categorized by the "Discharge Algorithm for Patients with Ileostomies." The algorithm will assign patients by their ileostomy output and determine their next management steps. After discharge, all patients will record their fluid input and output using the "Daily Measurement of Intake/Output Worksheet" which will be used to monitor hydration over time. Patients who are high risk will receive outpatient intravenous hydration therapy. At each intravenous therapy appointment, the health care provider will review the Outpatient Intravenous Hydration Algorithm to determine the volume of fluid to distribute or if re-evaluation is necessary. Data Collection After starting the standardized hydration protocol, researchers will prospectively collect data from monthly reports of patients who received an ileostomy creation. Researchers will not mask the patients, care providers, investigators, and outcomes assessors.

Conditions

Interventions

TypeNameDescription
PROCEDUREIntravenous HydrationPatients will receive daily intravenous hydration of normal saline based on their ileostomy output.

Timeline

Start date
2023-01-01
Primary completion
2024-01-01
Completion
2025-01-01
First posted
2020-12-17
Last updated
2023-02-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04669964. Inclusion in this directory is not an endorsement.