Gastric Emptying in Elderly With Hip Fracture (GASEMPHIP)

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fracture; Gastroparesis; Mild Insufficient Nutrition
• Intervention / Treatment: Procedure: Gastric emptying of carbohydrate-rich beverage; Procedure: Gastric emptying of carbohydrate-rich beverage; Procedure: Gastric emptying of carbohydrate-rich beverage

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 Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute hip fracture; Women preoperatively with acute hip fracture with gastric emptying of carbohydrate-rich beverage	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.; Other Names: Gastric emptying of beverage (Nutricia Preop; Numico); 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..; Other Names: Gastric emptying of beverage (Nutricia Preop; Numico); 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.; Other Names: Gastric emptying of beverage (Nutricia Preop; Numico)
Elective hip replacement; Women on waiting list for elective hip replacement with gastric emptying of carbohydrate-rich beverage	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.; Other Names: Gastric emptying of beverage (Nutricia Preop; Numico); 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..; Other Names: Gastric emptying of beverage (Nutricia Preop; Numico); 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.; Other Names: Gastric emptying of beverage (Nutricia Preop; Numico)
Healthy volunteers; Healthy female volunteers with gastric emptying of carbohydrate-rich beverage	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.; Other Names: Gastric emptying of beverage (Nutricia Preop; Numico); 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..; Other Names: Gastric emptying of beverage (Nutricia Preop; Numico); 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.; Other Names: Gastric emptying of beverage (Nutricia Preop; Numico)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gastric emptying	0-180 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Gastric lag phase	0-60 minutes
Pulmonary aspiration	0-180 minutes

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: April 17, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (ESTIMATE): April 27, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 27, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Gastrointestinal Diseases; Stomach Diseases; Femoral Fractures; Hip Injuries; Paralysis; Fractures, Bone; Hip Fractures; Gastroparesis
• Other Study ID Numbers: GASEMPHIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO