NCT07198308

Brief Summary

Heart rate variability (HRV) is a simple way to check how well the body's automatic nervous system is working. It does this by looking at how the heart rate changes in the electrocardiogram. HRV can be divided into time domain and frequency domain. Time domain indicators assess the tone of the autonomic nerves. Frequency domain indicators reflect the regulation of the sympathetic and parasympathetic nerves. An imbalance of the body's nervous system can be reflected by HRV. Stress hyperglycemia (SIH) is when your blood glucose levels go up because of an acute disease. This is usually related to the body's stress response, but if your blood glucose levels go up too much, it can lead to complications. A high blood sugar level caused by stress is common in intensive care units. There is a strong link between this and the death rate and how long patients stay there. There are lots of nerve endings in the pancreas. Nerve fibres control the way islet α/β cells work to keep the right amount of glucose in the blood. We know that the pancreatic nerve is important for controlling blood glucose levels, but we don't fully understand how it does this.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

September 22, 2025

Last Update Submit

March 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between glucagon and HRV in non-diabetic critically ill patients

    From enrollment to completion of indicator testing (within 24 hours)

Secondary Outcomes (1)

  • The correlation between blood glucose and random insulin levels and HRV in non-diabetic critically ill patients

    From enrollment to completion of indicator testing (within 24 hours)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who were hospitalized in the Intensive Care Unit of Zhongshan Hospital Affiliated to Fudan University after the start of the study.

You may qualify if:

  • Aged from 18 to 99 years old
  • Informed consent has been signed

You may not qualify if:

  • Under 18 years old
  • Diagnosed with diabetes either prior to or during hospitalization
  • Missing HRV values
  • Missing blood glucose and random insulin values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

September 30, 2025

Study Start

October 1, 2025

Primary Completion

December 31, 2025

Study Completion

March 13, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations