Gastric Emptying in Elderly With Hip Fracture

Completed

• Conditions: Hip Fracture; Mild Insufficient Nutrition; Gastroparesis
• Interventions: Procedure: Gastric emptying of carbohydrate-rich beverage

• Registration Number: NCT02753010
• Lead Sponsor: Uppsala University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Study First Submitted: 2016-04-17
• Study First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Study First Posted: 2016-04-27
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Gastric emptying	0-180 minutes

Secondary Outcome Measures

Name	Time	Method
Pulmonary aspiration	0-180 minutes
Gastric lag phase	0-60 minutes