Internal Jugular VeinNCT07879287
Internal Jugular Vein and Inferior Vena Cava Collapsibility Indices as a Guidance of Fluid Responsiveness in Septic Shock Cancer Patients
An observational study of Internal Jugular Vein and Inferior Vena Cava, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to compare between internal jugular vein and inferior vena cava collapsibility indices as a guidance of fluid responsiveness in septic shock cancer patients. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Internal Jugular Vein, Inferior Vena Cava, Collapsibility Indices
- What is being tested?
- Ultrasonographic assessment of internal jugular vein (IJV) collapsibility and Ultrasonographic assessment of inferior vena cava (IVC) collapsibility
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Prospective cohort study was conducted on adult cancer patients from Intensive care unit at National Cancer Institute Cairo University recently diagnosed with septic shock, spontaneously breathing and matching the inclusion criteria.
Who may be able to join
- Age (20-60) year.
- Cancer patient meeting criteria of septic shock.
- Mean arterial pressure <65 mmHg.
- Serum lactate >2 mmol /L.
- Evident source of infection.
Who cannot join
- Patient or relatives' refusal.
- Body mass index > 40
- Hypertension.
- Current or past history of:
- Right sided heart failure.
- Cor pulmonale.
Show all 11Show fewer
- Tricuspid valve lesion.
- Atrial fibrillation.
- Radiotherapy, surgery or trauma to the neck.
- Jugular vein thrombosis.
- Deep venous thrombosis of upper extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Internal Jugular Vein and Inferior Vena Cava Collapsibility Indices as a Guidance of Fluid Responsiveness in Septic Shock Cancer Patients
This study aimed to compare between internal jugular vein and inferior vena cava collapsibility indices as a guidance of fluid responsiveness in septic shock cancer patients.
Read the detailed description
Sepsis is a life-threatening organ dysfunction due to a dysregulated host response to infection. Most common infection is bacterial but it may be viral, fungal or protozoal. Risk factors include weak immune system, old age, malignancy, and burn.
Septic shock is defined as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities substantially increase mortality.
During spontaneous inspiration, negative intrathoracic pressure increases venous flow to the heart and reduces the inferior vena cava (IVC) diameter. At end expiration, the intrathoracic pressure increases to zero, decreasing the venous return and maximizing the IVC diameter. This has been defined as collapsibility index (CI).
Inferior vena cava may be difficult to be assessed by ultrasonography in patients with morbid obesity, abdominal distension, pregnancy and surgical drains. While the internal jugular vein (IJV) is easily accessible.
The collapsibility index of the inferior vena cava (cIVC) has potential for predicting fluid responsiveness in spontaneously breathing patients.
- Conditions
- Internal Jugular Vein, Inferior Vena Cava, Collapsibility Indices, Fluid Responsiveness, Septic Shock, Cancer
- Being tested
- Ultrasonographic assessment of internal jugular vein (IJV) collapsibility, Ultrasonographic assessment of inferior vena cava (IVC) collapsibility
- Medical subject headings
- Shock, Septic, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic assessment of internal jugular vein (IJV) collapsibilityDevice
Ultrasonography was used to measure the maximum and minimum anteroposterior diameters of the internal jugular vein (IJV) during a respiratory cycle, using linear and phased-array probes, respectively. The collapsibility index will be calculated as (maximum diameter - minimum diameter)/maximum diameter.
Ultrasonographic assessment of inferior vena cava (IVC) collapsibilityDevice
Ultrasonography was used to measure the maximum and minimum anteroposterior diameters of the inferior vena cava (IVC) during a respiratory cycle, using linear and phased-array probes, respectively. The collapsibility index will be calculated as (maximum diameter - minimum diameter)/maximum diameter.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Cancer patients with septic shock Receives: Device: Ultrasonographic assessment of internal jugular vein (IJV) collapsibility; Device: Ultrasonographic assessment of inferior vena cava (IVC) collapsibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Internal Jugular Vein Collapsibility Index
The area under the receiver operating characteristic (ROC) curve was calculated to evaluate the ability of the baseline internal jugular vein collapsibility index to predict fluid responsiveness following intravenous administration of 500 mL of 0.9% sodium chloride over 10 minutes. The collapsibility index was calculated as (maximum diameter - minimum diameter)/maximum diameter using ultrasonographic measurements during a respiratory cycle.
Measured: After completion of the 10-minute fluid challenge
Secondary outcomes (5)
Assessment of Inferior Vena Cava Collapsibility Index
The area under the receiver operating characteristic (ROC) curve was calculated to evaluate the ability of the baseline inferior vena cava collapsibility index to predict fluid responsiveness after the fluid challenge. The index was calculated as (maximum diameter - minimum diameter)/maximum diameter using ultrasonography.
Measured: After completion of the 10-minute fluid challenge
Change in Mean Arterial Pressure
Change in mean arterial pressure, measured in mmHg, calculated as the post-fluid-challenge value minus the baseline value.
Measured: After completion of the 10-minute fluid challenge
Change in Heart Rate
Change in heart rate, measured in beats per minute, calculated as the post-fluid-challenge value minus the baseline value.
Measured: After completion of the 10-minute fluid challenge
Change in Cardiac Output
Change in cardiac output, measured in L/min using electrical cardiometry, calculated as the post-fluid-challenge value minus the baseline value.
Measured: After completion of the 10-minute fluid challenge
Change in Pulse Pressure
Change in pulse pressure, measured in mmHg as systolic blood pressure minus diastolic blood pressure, calculated as the post-fluid-challenge value minus the baseline value.
Measured: After completion of the 10-minute fluid challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jul 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Jugular VeinStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Abdelrahman Hammad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879287
- Sponsor's protocol ID
- 2304-301-076
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Internal Jugular Vein and Inferior Vena Cava Collapsibility Indices as a Guidance of Fluid Responsiveness in Septic Shock Cancer Patients
- ClinicalTrials.gov ID
- NCT07879287
- Acronym / sponsor ID
- 2304-301-076
- Conditions
- Internal Jugular Vein, Inferior Vena Cava, Collapsibility Indices, Fluid Responsiveness, Septic Shock, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to compare between internal jugular vein and inferior vena cava collapsibility indices as a guidance of fluid responsiveness in septic shock cancer patients.
Detailed description
Sepsis is a life-threatening organ dysfunction due to a dysregulated host response to infection. Most common infection is bacterial but it may be viral, fungal or protozoal. Risk factors include weak immune system, old age, malignancy, and burn.
Septic shock is defined as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities substantially increase mortality.
During spontaneous inspiration, negative intrathoracic pressure increases venous flow to the heart and reduces the inferior vena cava (IVC) diameter. At end expiration, the intrathoracic pressure increases to zero, decreasing the venous return and maximizing the IVC diameter. This has been defined as collapsibility index (CI).
Inferior vena cava may be difficult to be assessed by ultrasonography in patients with morbid obesity, abdominal distension, pregnancy and surgical drains. While the internal jugular vein (IJV) is easily accessible.
The collapsibility index of the inferior vena cava (cIVC) has potential for predicting fluid responsiveness in spontaneously breathing patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Ultrasonographic assessment of internal jugular vein (IJV) collapsibility, Device: Ultrasonographic assessment of inferior vena cava (IVC) collapsibilityCancer patients with septic shock |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Prospective cohort study was conducted on adult cancer patients from Intensive care unit at National Cancer Institute Cairo University recently diagnosed with septic shock, spontaneously breathing and matching the inclusion criteria.
Key inclusion criteria (5 listed)
- Age (20-60) year.
- Cancer patient meeting criteria of septic shock.
- Mean arterial pressure <65 mmHg.
- Serum lactate >2 mmol /L.
- Evident source of infection.
Key exclusion criteria (11 listed)
- Patient or relatives' refusal.
- Body mass index > 40
- Hypertension.
- Current or past history of:
- Right sided heart failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic assessment of internal jugular vein (IJV) collapsibilityUltrasonography was used to measure the maximum and minimum anteroposterior diameters of the internal jugular vein (IJV) during a respiratory cycle, using linear and phased-array probes, respectively. The collapsibility index will be calculated as (maximum diameter - minimum diameter)/maximum diameter. | Device | Study group |
| Ultrasonographic assessment of inferior vena cava (IVC) collapsibilityUltrasonography was used to measure the maximum and minimum anteroposterior diameters of the inferior vena cava (IVC) during a respiratory cycle, using linear and phased-array probes, respectively. The collapsibility index will be calculated as (maximum diameter - minimum diameter)/maximum diameter. | Device | Study group |
Primary outcome
Assessment of Internal Jugular Vein Collapsibility Index
Time frame: After completion of the 10-minute fluid challenge
The area under the receiver operating characteristic (ROC) curve was calculated to evaluate the ability of the baseline internal jugular vein collapsibility index to predict fluid responsiveness following intravenous administration of 500 mL of 0.9% sodium chloride over 10 minutes. The collapsibility index was calculated as (maximum diameter - minimum diameter)/maximum diameter using ultrasonographic measurements during a respiratory cycle.
5 secondary outcomes
Assessment of Inferior Vena Cava Collapsibility Index
Time frame: After completion of the 10-minute fluid challenge
Change in Mean Arterial Pressure
Time frame: After completion of the 10-minute fluid challenge
Change in Heart Rate
Time frame: After completion of the 10-minute fluid challenge
Change in Cardiac Output
Time frame: After completion of the 10-minute fluid challenge
Change in Pulse Pressure
Time frame: After completion of the 10-minute fluid challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Internal Jugular Vein and Inferior Vena Cava, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Internal Jugular Vein Collapsibility Index (time frame: After completion of the 10-minute fluid challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.