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Gastroparesis as an Early Sign of Sepsis

NCT ID: NCT06240585

Last Updated: 2025-05-13

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

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroparesis and Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with ICU-acquired bacteremia

presence of gastroparesis as an early sign for sepsis (bacteremia)- measurement of gastric residual volume

Intervention Type OTHER

presence of gastroparesis as an early sign for sepsis (bacteremia)-measurement of gastric residual volume

patients without ICU-acquired bacteremia

No interventions assigned to this group

Interventions

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presence of gastroparesis as an early sign for sepsis (bacteremia)- measurement of gastric residual volume

presence of gastroparesis as an early sign for sepsis (bacteremia)-measurement of gastric residual volume

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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sara dichtwald

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0027-24-MMC

Identifier Type: -

Identifier Source: org_study_id

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