Clinical trial NCT06240585: Gastroparesis as an Early Sign of Sepsis
Official title: Gastroparesis as an Early Sign of Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroparesis and Sepsis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acquired ICU bacteremia

Brief 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. 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.


Eligibility criteria: 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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Primary outcomes:
measure: gastroparesis as an early sign for sepsis (bacteremia)
timeFrame: 24 hours before appearance of bacteremia
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References: