GastroparesisGASEMPHIPNCT02753010
Gastric Emptying in Elderly With Hip Fracture
An observational study of Gastroparesis and Hip Fracture, run by Uppsala University.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis, Hip Fracture, Mild Insufficient Nutrition
- What is being tested?
- Gastric emptying of carbohydrate-rich beverage
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- female gender, age 75 years or above, and hip fracture within 24 hours of admission.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastroparesis, Hip Fracture, Mild Insufficient Nutrition
- Being tested
- Gastric emptying of carbohydrate-rich beverage
- Medical subject headings
- Gastroparesis, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric emptying of carbohydrate-rich beverageProcedure or surgery
Also called Gastric emptying of beverage (Nutricia Preop; Numico)
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.
Gastric emptying of carbohydrate-rich beverageProcedure or surgery
Also called Gastric emptying of beverage (Nutricia Preop; Numico)
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..
Gastric emptying of carbohydrate-rich beverageProcedure or surgery
Also called Gastric emptying of beverage (Nutricia Preop; Numico)
Young healthy women with intake of carbohydrate-rich beverage in order to improve metabolic control. Gastric emptying studied as comparator in young women.
| Study group | Role | What they receive |
|---|---|---|
| Acute hip fracture | Women preoperatively with acute hip fracture with gastric emptying of carbohydrate-rich beverage Receives: Procedure: Gastric emptying of carbohydrate-rich beverage | |
| Elective hip replacement | Women on waiting list for elective hip replacement with gastric emptying of carbohydrate-rich beverage Receives: Procedure: Gastric emptying of carbohydrate-rich beverage | |
| Healthy volunteers | Healthy female volunteers with gastric emptying of carbohydrate-rich beverage Receives: Procedure: Gastric emptying of carbohydrate-rich beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying
Measured: 0-180 minutes
Secondary outcomes (2)
Gastric lag phase
Measured: 0-60 minutes
Pulmonary aspiration
Measured: 0-180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMar 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Per Hellström, Uppsala University
- Investigators
- Margareta Hedström, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753010
- Sponsor's protocol ID
- GASEMPHIP
- Acronym
- GASEMPHIP
- Status last verified
- Apr 2016
- First submitted
- 17 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 28202056
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying Time of a Carbohydrate-rich Drink in Elderly Patients With Acute Hip Fracture: a Pilot Study
- ClinicalTrials.gov ID
- NCT02753010
- Acronym / sponsor ID
- GASEMPHIP / GASEMPHIP
- Conditions
- Gastroparesis, Hip Fracture, Mild Insufficient Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Mar 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute hip fracture | – | Procedure: Gastric emptying of carbohydrate-rich beverageWomen preoperatively with acute hip fracture with gastric emptying of carbohydrate-rich beverage |
| Elective hip replacement | – | Procedure: Gastric emptying of carbohydrate-rich beverageWomen on waiting list for elective hip replacement with gastric emptying of carbohydrate-rich beverage |
| Healthy volunteers | – | Procedure: Gastric emptying of carbohydrate-rich beverageHealthy female volunteers with gastric emptying of carbohydrate-rich beverage |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- female gender, age 75 years or above, and hip fracture within 24 hours of admission.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric emptying of carbohydrate-rich beverageAlso: Gastric emptying of beverage (Nutricia Preop; Numico)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. | Procedure or surgery | Acute hip fracture |
| Gastric emptying of carbohydrate-rich beverageAlso: Gastric emptying of beverage (Nutricia Preop; Numico)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.. | Procedure or surgery | Elective hip replacement |
| Gastric emptying of carbohydrate-rich beverageAlso: Gastric emptying of beverage (Nutricia Preop; Numico)Young healthy women with intake of carbohydrate-rich beverage in order to improve metabolic control. Gastric emptying studied as comparator in young women. | Procedure or surgery | Healthy volunteers |
Primary outcome
Gastric emptying
Time frame: 0-180 minutes
2 secondary outcomes
Gastric lag phase
Time frame: 0-60 minutes
Pulmonary aspiration
Time frame: 0-180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Derived from this study: PubMed 28202056Hellstrom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margareta Hedström, MD, PhD study director
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Hip Fracture, run by Uppsala University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying (time frame: 0-180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.