Gastric Emptying in Elderly With Hip Fracture

NCT ID: NCT02753010

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Gastroparesis Hip Fracture Mild Insufficient Nutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute hip fracture

Women preoperatively with acute hip fracture with gastric emptying of carbohydrate-rich beverage

Gastric emptying of carbohydrate-rich beverage

Intervention Type 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.

Elective hip replacement

Women on waiting list for elective hip replacement with gastric emptying of carbohydrate-rich beverage

Gastric emptying of carbohydrate-rich beverage

Intervention Type PROCEDURE

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..

Healthy volunteers

Healthy female volunteers with gastric emptying of carbohydrate-rich beverage

Gastric emptying of carbohydrate-rich beverage

Intervention Type PROCEDURE

Young healthy women with intake of carbohydrate-rich beverage in order to improve metabolic control. Gastric emptying studied as comparator in young women.

Interventions

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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.

Intervention Type 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..

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Gastric emptying of beverage (Nutricia Preop; Numico) Gastric emptying of beverage (Nutricia Preop; Numico) Gastric emptying of beverage (Nutricia Preop; Numico)

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Per Hellström

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margareta Hedström, MD, PhD

Role: STUDY_DIRECTOR

Karolinska Institutet

References

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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.

Reference Type DERIVED
PMID: 28202056 (View on PubMed)

Other Identifiers

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GASEMPHIP

Identifier Type: -

Identifier Source: org_study_id

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