Clinical trial NCT02753010: Gastric Emptying in Elderly With Hip Fracture
Official title: Gastric Emptying Time of a Carbohydrate-rich Drink in Elderly Patients With Acute Hip Fracture: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroparesis
Hip Fracture
Mild Insufficient Nutrition
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2016-04-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly women with acute hip fracture awaiting surgery within the next 24 hours. Since surgery is performed early next morning, patients will be kept fasted for prolonged periods of time with only continuous line of glucose 5% or 10% solution. This will not evoke any insulin response which is needed for controlled metabolic condition.

In addition: Patients elective for hip replacement, healthy volunteers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastric emptying
timeFrame: 0-180 minutes
Secondary outcomes:
measure: Gastric lag phase
timeFrame: 0-60 minutes
measure: Pulmonary aspiration
timeFrame: 0-180 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Margareta Hedström, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Hellstrom PM, Samuelsson B, Al-Ani AN, Hedstrom M. Normal gastric emptying time of a carbohydrate-rich drink in elderly patients with acute hip fracture: a pilot study. BMC Anesthesiol. 2017 Feb 15;17(1):23. doi: 10.1186/s12871-016-0299-6.