Gastroparesis and SepsisNCT06240585
Gastroparesis as an Early Sign of Sepsis
An observational study of Gastroparesis and Sepsis, run by Meir Medical Center at 1 site in Israel.
Trial summary
Upper gastrointestinal tract disorders, such as gastroparesis, are common in critically ill patients in the ICU, estimated at 60%. Gastroparesis symptoms include nausea, vomiting and abdominal pain. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gastroparesis and Sepsis
- What is being tested?
- presence of gastroparesis as an early sign for sepsis (bacteremia)- measurement of gastric residual volume
- How many people
- 260 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2024to 1 May 2025
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acquired ICU bacteremia
Inclusion Criteria: Patients aged 18--99 who were admitted to the general intensive care unit from January 2015 to April 2021, and who were diagnosed with acquired bacteremia in the ICU (positive blood culture after 48 hours or more from ICU admission). As a control group we will collect data regarding a similar number of patients who were admitted during this time period but were not diagnosed with acquired bacteremia or sepsis during their stay in the unit.
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Exclusion Criteria: Patients who did not meet the above criteria or for whom data were missing. Likewise, patients who did not have a nasogastric tube will be excluded (we cannot test gastirc residual volume) as well as patients who were admitted after abdominal surgery (gastroparesis is a common finding in these patients regardless of sepsis and may be a confounder. In addition, acquired bacteremia in these patients could be the result of a surgical complication, such as intra-abdominal sepsis secondary to intestinal leak etc., and gastroparesis usually accompanies abdominal sepsis and will not be the result of sepsis per-se).
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Trial locations and contacts
1 site in 1 country.
About this study
Upper gastrointestinal tract disorders, such as gastroparesis, are common in critically ill patients in the ICU, estimated at 60%. Gastroparesis symptoms include nausea, vomiting and abdominal pain. Risk factors for the development of gastroparesis include diabetes, surgical injury to the vagus nerve (such as certain types of bariatric surgery, and in the past - surgeries for patients who suffered from peptic ulcer), use of drugs that inhibit the activity of the digestive system such as opiates, anticholinergic drugs, sepsis, as well as being bedridden and inactive - are all common conditions in critically ill patients.
There are different definitions for gastroparesis. One of the accepted definitions refers to gastric residual volume (GRV) over 200 ml at one measurement. Gastroparesis is found in some studies to be associated with increased morbidity and mortality in critically ill patients. As mentioned above, it is known that sepsis is a risk factor for gastroparesis. According to our experience based on treatment of a large number of septic patients, we have the impression that often gastroparesis is an early sign for the development of sepsis. We did not find any studies that tested this hypothesis.
In this study we would like to investigate whether the development of gastroparesis in critical patients in intensive care can be a predictive sign for the development of sepsis.
- Conditions
- Gastroparesis and Sepsis
- Being tested
- presence of gastroparesis as an early sign for sepsis (bacteremia)- measurement of gastric residual volume
- Medical subject headings
- Gastroparesis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
presence of gastroparesis as an early sign for sepsis (bacteremia)- measurement of gastric residual volumeOther
presence of gastroparesis as an early sign for sepsis (bacteremia)-measurement of gastric residual volume
| Study group | Role | What they receive |
|---|---|---|
| patients with ICU-acquired bacteremia | Not described Receives: Other: presence of gastroparesis as an early sign for sepsis (bacteremia)- measurement of gastric residual volume | |
| patients without ICU-acquired bacteremia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastroparesis as an early sign for sepsis (bacteremia)
Measured: 24 hours before appearance of bacteremia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Jun 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroparesis and SepsisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240585
- Sponsor's protocol ID
- 0027-24-MMC
- Status last verified
- May 2025
- First submitted
- 26 Jan 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroparesis as an Early Sign of Sepsis
- ClinicalTrials.gov ID
- NCT06240585
- Acronym / sponsor ID
- 0027-24-MMC
- Conditions
- Gastroparesis and Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- 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.
Upper gastrointestinal tract disorders, such as gastroparesis, are common in critically ill patients in the ICU, estimated at 60%. Gastroparesis symptoms include nausea, vomiting and abdominal pain. Risk factors for the development of gastroparesis include diabetes, surgical injury to the vagus nerve (such as certain types of bariatric surgery, and in the past - surgeries for patients who suffered from peptic ulcer), use of drugs that inhibit the activity of the digestive system such as opiates, anticholinergic drugs, sepsis, as well as being bedridden and inactive - are all common conditions in critically ill patients.
There are different definitions for gastroparesis. One of the accepted definitions refers to gastric residual volume (GRV) over 200 ml at one measurement. Gastroparesis is found in some studies to be associated with increased morbidity and mortality in critically ill patients. As mentioned above, it is known that sepsis is a risk factor for gastroparesis. According to our experience based on treatment of a large number of septic patients, we have the impression that often gastroparesis is an early sign for the development of sepsis. We did not find any studies that tested this hypothesis.
In this study we would like to investigate whether the development of gastroparesis in critical patients in intensive care can be a predictive sign for the development of sepsis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with ICU-acquired bacteremia | – | Other: presence of gastroparesis as an early sign for sepsis (bacteremia)- measurement of gastric residual volume |
| patients without ICU-acquired bacteremia | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acquired ICU bacteremia
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 |
|---|---|---|
| presence of gastroparesis as an early sign for sepsis (bacteremia)- measurement of gastric residual volumepresence of gastroparesis as an early sign for sepsis (bacteremia)-measurement of gastric residual volume | Other | patients with ICU-acquired bacteremia |
Primary outcome
gastroparesis as an early sign for sepsis (bacteremia)
Time frame: 24 hours before appearance of bacteremia
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 13 May 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Sepsis, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
gastroparesis as an early sign for sepsis (bacteremia) (time frame: 24 hours before appearance of bacteremia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2025.