Gastroparesis as an Early Sign of Sepsis

NCT06240585 | Completed

• 1 other identifier: 0027-24-MMC
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis and Sepsis

Outcome Measures

Primary Outcomes (1)

• gastroparesis as an early sign for sepsis (bacteremia)

  24 hours before appearance of bacteremia

Study Arms (2)

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

Interventions

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

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

patients with ICU-acquired bacteremia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acquired ICU bacteremia

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Gastroparesis; Sepsis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: June 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

IL (1)