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Completed

NCT Number: NCT02753010

Gastric Emptying in Elderly With Hip Fracture

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric emptying of carbohydrate-rich beverage

Procedure

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.

Other names: Gastric emptying of beverage (Nutricia Preop; Numico)

Primary outcomes

  1. Gastric emptying

    Time frame: 0-180 minutes

Secondary outcomes

  1. Gastric lag phase

    Time frame: 0-60 minutes

  2. Pulmonary aspiration

    Time frame: 0-180 minutes

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Acronym: GASEMPHIP

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Apr 27, 2016
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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