Gastric Emptying in Elderly With Hip Fracture (GASEMPHIP)

April 26, 2016 updated by: Per Hellström, Uppsala University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Gastric emptying
Time Frame: 0-180 minutes
0-180 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Gastric lag phase
Time Frame: 0-60 minutes
0-60 minutes
Pulmonary aspiration
Time Frame: 0-180 minutes
0-180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GASEMPHIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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