NCT06557629

Brief Summary

Enteral nutrition intolerance, manifested in delayed gastric emptying and high gastric residual, is a common problem in critically ill patients in intensive care, with adverse consequences on patients' outcomes. A decrease in the levels of the ghrelin hormone in these patients may contribute to this problem. The gastric residual test (GRV) is used to assess enteral absorption and gastric motility, but the traditional methods can lead to inaccuracy and waste of resources. In recent years, the use of ultrasound (PoCUS) to assess GRV has developed, but its effect on the rate of reaching the caloric goal has not yet been evaluated.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Oct 2024Oct 2027

First Submitted

Initial submission to the registry

August 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

August 14, 2024

Last Update Submit

May 7, 2025

Conditions

Enteral Nutrition Intolerance in Critically Ill Patients

Outcome Measures

Primary Outcomes (1)

  • Reaching the daily caloric goal

    To compare the daily caloric goal via gastric residual volume assessment with ultrasound vs. gastric aspiration

    3 days

Study Arms (2)

Ultrasound group

EXPERIMENTAL

Assessment of gastric residual volume via US

Diagnostic Test: Ultrasound assessment

Aspiration group

NO INTERVENTION

assessment of gastric residual volume via aspiration of gastric content

Interventions

Ultrasound assessmentDIAGNOSTIC_TEST

Ultrasound assessment of gastric residual volume

Ultrasound group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 16, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations

IL(1)