Evaluating Ileostomy Hydration Protocol

Dehydration Clinical Trial

Official title:

Evaluating the Efficacy of a Standardized Hydration Protocol After Ileostomy Creation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04669964
• Other study ID #: 2011-73
• Status: Withdrawn
• Start date: January 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2023
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years of age will be eligible for this study.

• Patients who received emergent or elective end or loop ileostomy during the index admission will be eligible for this study.

Exclusion criteria:

• Patients who have not received an ileostomy creation at Robert Packer Hospital will be ineligible.

Related Conditions & MeSH terms

• Dehydration
• Ileostomy - Stoma
• Ileostomy; Complications

Intervention

Procedure:
• Intravenous Hydration
Patients will receive daily intravenous hydration of normal saline based on their ileostomy output.

Locations

Country	Name	City	State
United States	Guthrie Robert Packer Hospital	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

References & Publications (11)

Abdalla S, Scarpinata R. Early and Late Closure of Loop Ileostomies: A Retrospective Comparative Outcomes Analysis. Ostomy Wound Manage. 2018 Dec;64(12):30-35. — View Citation

Ahmad SJ, Khan A, Madhotra R, K Exadaktylos A, Milioto ME, Macfaul G, Rostami K. Semi-elemental diet is effective in managing high output ileostomy; a case report. Gastroenterol Hepatol Bed Bench. 2019 Spring;12(2):169-173. — View Citation

Al-Mazrou AM, Suradkar K, Mauro CM, Kiran RP. Characterization of Readmission by Day of Rehospitalization After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):202-212. doi: 10.1097/DCR.0000000000000734. — View Citation

Bleier JI, Hedrick T. Metabolic support of the enterocutaneous fistula patient. Clin Colon Rectal Surg. 2010 Sep;23(3):142-8. doi: 10.1055/s-0030-1262981. — View Citation

Grass F, Lovely JK, Crippa J, Hubner M, Mathis KL, Larson DW. Potential Association Between Perioperative Fluid Management and Occurrence of Postoperative Ileus. Dis Colon Rectum. 2020 Jan;63(1):68-74. doi: 10.1097/DCR.0000000000001522. — View Citation

Kristensen K, Qvist N. The Acute Effect of Loperamide on Ileostomy Output: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Study. Basic Clin Pharmacol Toxicol. 2017 Dec;121(6):493-498. doi: 10.1111/bcpt.12830. Epub 2017 Jul 10. — View Citation

Murken DR, Bleier JIS. Ostomy-Related Complications. Clin Colon Rectal Surg. 2019 May;32(3):176-182. doi: 10.1055/s-0038-1676995. Epub 2019 Apr 2. — View Citation

Nagle D, Pare T, Keenan E, Marcet K, Tizio S, Poylin V. Ileostomy pathway virtually eliminates readmissions for dehydration in new ostomates. Dis Colon Rectum. 2012 Dec;55(12):1266-72. doi: 10.1097/DCR.0b013e31827080c1. — View Citation

Parli SE, Pfeifer C, Oyler DR, Magnuson B, Procter LD. Redefining "bowel regimen": Pharmacologic strategies and nutritional considerations in the management of small bowel fistulas. Am J Surg. 2018 Aug;216(2):351-358. doi: 10.1016/j.amjsurg.2018.01.040. Epub 2018 Feb 12. — View Citation

van Loon YT, Poylin VY, Nagle D, Zimmerman DDE. Effectiveness of the Ileostomy Pathway in Reducing Readmissions for Dehydration: Does It Stand the Test of Time? Dis Colon Rectum. 2020 Aug;63(8):1151-1155. doi: 10.1097/DCR.0000000000001627. — View Citation

Vergara-Fernandez O, Trejo-Avila M, Santes O, Solorzano-Vicuna D, Salgado-Nesme N. Predictors of dehydration and acute renal failure in patients with diverting loop ileostomy creation after colorectal surgery. World J Clin Cases. 2019 Jul 26;7(14):1805-1813. doi: 10.12998/wjcc.v7.i14.1805. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission with 30 days	Unplanned hospital readmission within 30 days of ileostomy creation. Researchers will determine unplanned hospital readmissions through monthly generated patient reports and validated by chart review.	30 days after discharge for ileostomy creation
Secondary	Readmission	Unplanned hospital readmission within 60 and 90 days of surgery. Researchers will determine unplanned hospital readmissions through monthly generated patient reports and validated by chart review.	60 and 90 days after discharge for ileostomy creation
Secondary	Emergency Department Visits	Emergency department visits within 30, 60, and 90 days of surgery. Researchers will determine emergency department visits through monthly generated patient reports and validated by chart review.	30, 60, and 90 days after discharge for ileostomy creation
Secondary	Dehydration Events	The number of clinically significant dehydration events within 30, 60, and 90 days of surgery. Researchers will determine the number of clinically significant dehydration events through monthly generated patient reports and validated by chart review.	30, 60, and 90 days after discharge for ileostomy creation
Secondary	Reoperation	The incidence of reoperation within 30, 60, and 90 days of surgery. Researchers will determine the incidence of reoperation through monthly generated patient reports and validated by chart review.	30, 60, and 90 days after discharge for ileostomy creation
Secondary	Mortality	Mortality rates within 30, 60, and 90 days of surgery. Researchers will determine mortality through monthly generated patient reports and validated by chart review	30, 60, and 90 days after discharge for ileostomy creation

External Links

•   Study from the Agency for Healthcare Research and Quality estimated that the mean cost per readmission for ileostomy procedures is $15,434