Gastric Emptying in Elderly With Hip Fracture

Overview

The gastric emptying of 400 ml 12.6% carbohydrate rich drink is investigated in elderly women, age 75-100, with acute hip fracture. The emptying time will be assessed by the paracetamol absorption technique, and lag phase and gastric half-emptying time compared with two gender-matched reference groups: elective hip replacement patients, age 45-71, and healthy volunteers, age 28-55.

Full Title of Study: “Gastric Emptying Time of a Carbohydrate-rich Drink in Elderly Patients With Acute Hip Fracture: a Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2016

Detailed Description

Patients with hip fracture are submitted to prolonged fasting before surgery is undertaken. This is deleterious for their metabolic condition and slows recovery after surgery. A carbohydrate-rich beverage is taken immediately before surgery and gastric emptying rate is assessed in elderly (75-100 yo) women prior to surgery for acute hip fracture. As comparator another two groups of women are used; one scheduled for elective surgery for hip replacement due to osteoarthritis; another healthy female volunteers. On the day of surgery the primary study group of acute hip fracture is given a carbohydrate-rich beverage 400 ml, total 200 kcal in combination with paracetamol 1.5 g. Blood samples are intermittently drawn during 180 minutes to measure recovery of paracetamol in plasma and gastric emptying rate calculated according to previously published principles. In the same manner a group of women on waiting list for hip replacement surgery due to osteoarthritis are enrolled for estimation of gastric emptying rate. In addition, another group of completely healthy women are enrolled for assessment of gastric emptying.

Interventions

  • Procedure: Gastric emptying of carbohydrate-rich beverage
    • Old women with acute hip fracture with intake of carbohydrate-rich beverage in order to improve metabolic control. Gastric emptying studied for retention in the elderly with acute trauma.
  • Procedure: Gastric emptying of carbohydrate-rich beverage
    • Old women on waiting list for hip joint replacement with intake of carbohydrate-rich beverage in order to improve metabolic control. Gastric emptying studied as comparator in the elderly without acute trauma..
  • Procedure: Gastric emptying of carbohydrate-rich beverage
    • Young healthy women with intake of carbohydrate-rich beverage in order to improve metabolic control. Gastric emptying studied as comparator in young women.

Arms, Groups and Cohorts

  • Acute hip fracture
    • Women preoperatively with acute hip fracture with gastric emptying of carbohydrate-rich beverage
  • Elective hip replacement
    • Women on waiting list for elective hip replacement with gastric emptying of carbohydrate-rich beverage
  • Healthy volunteers
    • Healthy female volunteers with gastric emptying of carbohydrate-rich beverage

Clinical Trial Outcome Measures

Primary Measures

  • Gastric emptying
    • Time Frame: 0-180 minutes

Secondary Measures

  • Gastric lag phase
    • Time Frame: 0-60 minutes
  • Pulmonary aspiration
    • Time Frame: 0-180 minutes

Participating in This Clinical Trial

Inclusion Criteria

  • female gender, age 75 years or above, and hip fracture within 24 hours of admission. Exclusion Criteria:

  • gastro-esophageal reflux disease, peptic ulcer disease, gastrointestinal motility disorder, pulmonary or cardiac disease, pharmacological treatment with motility-stimulating agents such as dopamine-receptor blockers or macrolides, as well as previous long-term opioids or acid inhibitory agents, or cognitive impairment at the discretion of the investigator

Gender Eligibility: Female

Minimum Age: 45 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Uppsala University
  • Collaborator
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Per Hellström, Professor, MD, PhD – Uppsala University
  • Overall Official(s)
    • Margareta Hedström, MD, PhD, Study Director, Karolinska Institutet

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