Evaluating Ileostomy Hydration Protocol

NCT04669964 | Withdrawn

• 1 other identifier: 2011-73
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ileostomy - Stoma; Ileostomy; Complications; Dehydration

Keywords

ileostomy; dehydration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Readmission

  60 and 90 days after discharge for ileostomy creation

• Emergency Department Visits

  30, 60, and 90 days after discharge for ileostomy creation

• Dehydration Events

  30, 60, and 90 days after discharge for ileostomy creation

• Reoperation

  30, 60, and 90 days after discharge for ileostomy creation

• Mortality

  30, 60, and 90 days after discharge for ileostomy creation

Study Arms (1)

High-Risk For Dehydration

Patients with an Ileostomy output of \>1L at discharge.

Procedure: Intravenous Hydration

Interventions

Intravenous Hydration PROCEDURE

Patients will receive daily intravenous hydration of normal saline based on their ileostomy output.

High-Risk For Dehydration

Eligibility Criteria

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

Study Population

All patients over the age of 18 years of age who received an emergent or elective end or loop ileostomy at Robert Packer Hospital.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Guthrie Clinic: lead

Study Sites (1)

Guthrie Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

Related Publications (11)

• 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.

  PMID: 31061647 BACKGROUND

• 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.

  PMID: 31417926 BACKGROUND

• 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.

  PMID: 31191843 BACKGROUND

• 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.

  PMID: 28059917 BACKGROUND

• 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.

  PMID: 30516478 BACKGROUND

• 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.

  PMID: 32692076 BACKGROUND

• 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.

  PMID: 23135585 BACKGROUND

• 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.

  PMID: 31633601 BACKGROUND

• 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.

  PMID: 28627732 BACKGROUND

• 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.

  PMID: 29448989 BACKGROUND

• 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.

  PMID: 21886463 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Burt Cagir M FACS

  Robert Packer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)