SepsisNCT06516692
Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.
A study testing Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment in people with Sepsis and Acute Renal Failure, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
This study will help in determining the impact of assessment of Inferior Vena Cava Collapsibility and Distensibility Index (IVC CI and DI) through Point Of Care Ultra Sound (POCUS), for the fluid management of critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis, Acute Renal Failure, Acute Gastroenteritis
- What is being tested?
- Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 30 Nov 2024
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted in critical care with systolic Blood Pressure < 90 mmHg with any of the diagnosis as per operational definition:
- Sepsis
- Diabetic ketoacidosis
- Acute kidney injury
- Acute gastroenteritis
Who cannot join
- Known case of right heart disease
- Known case of congestive cardiac failure
- Presence of marked ascites
- IVC could not be identified or diameter could not be measured
- Pregnant females
- Body Mass Index (BMI) >30 Kg/meter2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (IVCIN TRIAL) Outcomes of Patient Admitted to Critical Care Unit With vs Without Inferior Vena Cava Collapsibility and Distensibility Assessment. A Randomized Clinical Trial in Pakistan.
This study will help in determining the impact of assessment of Inferior Vena Cava Collapsibility and Distensibility Index (IVC CI and DI) through Point Of Care Ultra Sound (POCUS), for the fluid management of critically ill patients. This would help in better management of such patients in resource limited countries, where costly equipment for cardiac output monitoring and fluid management are frequently not available.
Moreover this study will help in development of future guidelines for fluid resuscitation in critically ill patients.
Read the detailed description
The current study is a randomized clinical trial with the aim to explore comparative outcome between IVC CI and DI versus clinical parameters guided fluid management groups in patients of sepsis, Acute renal failure, Acute gastroenteritis and Diabetic ketoacidosis in terms of,
- Within 24 hours 7 day and 28 day mortality
- Change in Sequential Organ failure Assessment (ΔSOFA) score from baseline to 24 hours after fluid management.
- Cumulative fluid balance at 6 hours of fluid management
- Days on mechanical ventilation
- Days in Intensive Care Unit (ICU)
- Change in lactic acid levels in sepsis sub group
- Change in Blood sugar Random (BSR) in Diabetic ketoacidosis (DKA) sub group
- Change in Power of Hydrogen (PH) in septic and diabetic ketoacidosis sub group of participant
- Being tested
- Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment
- Keywords
- Inferior Vena Cava Collapsibility and Distensibility index, Fluid management, Resuscitation, Clinical parameters, Sepsis, Acute gastroenteritis, Acute Renal failure, Diabetic ketoacidosis, Mortality, Cumulative fluid balance, Lactic acid, Sequential Organ Failure Assessment score, Mechanical Ventilation, Critical Care
- Medical subject headings
- Sepsis, Acute Kidney Injury, Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessmentDiagnostic test
Assessment of hydration status in critically ill patient recruited to this arm will be intervened through an ultrasound guided calculation of collapsibility and distensibility index of Inferior Vena Cava. This method of intervention will be continued and repeated as needed throughout the stay of the participant in intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Parameters guided assessment arm | No intervention | Participants recruited to this arm will be assessed for their hydration status and further fluid management as per usual care of assessment through * Capillary refill time * Presence/absence of pulmonary rales. * Jugular venous pressure assessment by clinical methods * Presence / absence of pedal edema |
| Inferior Vena Cava Collapsibility and Distensibility guided assessment arm | Experimental | Participants recruited in this arm will be assessed through measurement of inferior vena cava diameter via subcostal window within 3 cm of its opening to right atrium through point of care ultrasound using a curvilinear or phased array probe.
For spontaneously breathing patients Inferior Vena Cava Collapsibility Index (IVC CI) will be calculated as:
[(IVC diameter max-IVC diameter min)/IVC diameter max]×100%
* IVC CI > 50% = overt hypovolemia
* IVC CI < 20% = no overt hypovolemia
* IVC CI of 20% to 50% will be goal
For mechanically ventilated patients Inferior Vena Cava Distensibility Index (IVC DI) will be calculated as:
[(IVC diameter max-IVC diameter min)/IVC diameter min]×100% IVC distensibility>18% = hypovolemia IVC distensibility<18% = no hypovolemia Receives: Diagnostic Test: Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within 24-hours, 7-day and 28 day mortalities
Death of participant will be considered mortality.
Measured: Mortalities will be assessed and recorded within 24hour, then day 7 up to 28th day.
Cumulative fluid balance
A difference of total amount of fluids given both intravenously and through oral rout to a total amount of urine output or fluid removed during dialysis, calculated in milliliter (ml) will be taken as cumulative fluid balance.
Measured: At 6 hours of enrolment of participant
Change in Sequential Organ Failure Assessment score(Δ SOFA)
A difference will be noted in initial Sequential Organ Failure Assessment score ( from 0 up to 24) to score at 24 hours .A positive difference in score will be considered as improvement and a negative difference will be considered as worsening in outcomes. Values for cumulative SOFA scores as well as individual organ SOFA scores for hepatic, neurological, cardiovascular, renal, coagulopathy and respiratory will be analyzed.
Measured: At 24 hours of enrolment
Secondary outcomes (5)
Days in Intensive Care Unit (ICU)
Total ICU stay in days will be noted
Measured: ICU days up to 28 day
Days on mechanical ventilation
This outcome will be measured for the participants who will be mechanically ventilated.
Measured: Days in which participant will be on mechanical ventilation up to 28 days
Change in lactic acid levels in septic patient
This outcome will be measured as difference of values from the time of enrolment to 6 hours in mmol/L in patients with diagnosis of sepsis in the trial
Measured: At 6 hours of enrolment of participant
Change in Blood Sugar random (BSR) levels in patients with diabetic ketoacidosis
This outcome will be measured in mg/dL in patients with diagnosis of diabetic ketoacidosis in the trial
Measured: At 6 hours of enrolment of participant
Change in Power of hydrogen (PH) in patients with sepsis and diabetic ketoacidosis
This outcome will be calculated as difference of values from time of enrolment to 6 hours.
Measured: At 6 hours of enrolment of participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Aug 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shamim Kausar, EDIC,FCPS, Principal investigator, Jinnah Post Graduate and Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516692
- Sponsor's protocol ID
- NO.F.2-81/2023-GENL/64/JPMC
- Status last verified
- Dec 2024
- First submitted
- 12 Jul 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share Individual patient data.
Publications
Kashani K, Omer T, Shaw AD. The Intensivist's Perspective of Shock, Volume Management, and Hemodynamic Monitoring. Clin J Am Soc Nephrol. 2022 May;17(5):706-716. doi: 10.2215/CJN.14191021. Epub 2022 Apr 4.
PubMed 35379765Basmaji J, Arntfield R, Desai K, Lau VI, Lewis K, Rochwerg B, Fiorini K, Honarmand K, Slessarev M, Leligdowicz A, Park B, Prager R, Wong MYS, Jones PM, Ball IM, Orozco N, Meade M, Thabane L, Guyatt G. The Impact of Point-of-Care Ultrasound-Guided Resuscitation on Clinical Outcomes in Patients With Shock: A Systematic Review and Meta-Analysis. Crit Care Med. 2024 Nov 1;52(11):1661-1673. doi: 10.1097/CCM.0000000000006399. Epub 2024 Sep 18.
PubMed 39298556Musikatavorn K, Plitawanon P, Lumlertgul S, Narajeenron K, Rojanasarntikul D, Tarapan T, Saoraya J. Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock. West J Emerg Med. 2021 Feb 10;22(2):369-378. doi: 10.5811/westjem.2020.11.48571.
PubMed 33856325Spiliotaki E, Saranteas T, Moschovaki N, Panagouli K, Pistioli E, Kitsinelis V, Briasoulis P, Papadimos T. Inferior vena cava ultrasonography in the assessment of intravascular volume status and fluid responsiveness in the emergency department and intensive care unit: A critical analysis review. J Clin Ultrasound. 2022 Jun;50(5):733-744. doi: 10.1002/jcu.23194. Epub 2022 Mar 18.
PubMed 35302241Kaptein EM, Kaptein MJ. Inferior vena cava ultrasound and other techniques for assessment of intravascular and extravascular volume: an update. Clin Kidney J. 2023 Jun 29;16(11):1861-1877. doi: 10.1093/ckj/sfad156. eCollection 2023 Nov.
PubMed 37915939
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (IVCIN TRIAL) Outcomes of Patient Admitted to Critical Care Unit With vs Without Inferior Vena Cava Collapsibility and Distensibility Assessment. A Randomized Clinical Trial in Pakistan.
- ClinicalTrials.gov ID
- NCT06516692
- Acronym / sponsor ID
- NO.F.2-81/2023-GENL/64/JPMC
- Keywords
- Inferior Vena Cava Collapsibility and Distensibility index, Fluid management, Resuscitation, Clinical parameters, Sepsis, Acute gastroenteritis, Acute Renal failure, Diabetic ketoacidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 24 Jul 2024 (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 will help in determining the impact of assessment of Inferior Vena Cava Collapsibility and Distensibility Index (IVC CI and DI) through Point Of Care Ultra Sound (POCUS), for the fluid management of critically ill patients. This would help in better management of such patients in resource limited countries, where costly equipment for cardiac output monitoring and fluid management are frequently not available.
Moreover this study will help in development of future guidelines for fluid resuscitation in critically ill patients.
Detailed description
The current study is a randomized clinical trial with the aim to explore comparative outcome between IVC CI and DI versus clinical parameters guided fluid management groups in patients of sepsis, Acute renal failure, Acute gastroenteritis and Diabetic ketoacidosis in terms of,
- Within 24 hours 7 day and 28 day mortality
- Change in Sequential Organ failure Assessment (ΔSOFA) score from baseline to 24 hours after fluid management.
- Cumulative fluid balance at 6 hours of fluid management
- Days on mechanical ventilation
- Days in Intensive Care Unit (ICU)
- Change in lactic acid levels in sepsis sub group
- Change in Blood sugar Random (BSR) in Diabetic ketoacidosis (DKA) sub group
- Change in Power of Hydrogen (PH) in septic and diabetic ketoacidosis sub group of participant
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Parameters guided assessment arm | No intervention | –Participants recruited to this arm will be assessed for their hydration status and further fluid management as per usual care of assessment through * Capillary refill time * Presence/absence of pulmonary rales. * Jugular venous pressure assessment by clinical methods * Presence / absence of pedal edema |
| Inferior Vena Cava Collapsibility and Distensibility guided assessment arm | Experimental | Diagnostic Test: Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessmentParticipants recruited in this arm will be assessed through measurement of inferior vena cava diameter via subcostal window within 3 cm of its opening to right atrium through point of care ultrasound using a curvilinear or phased array probe. For spontaneously breathing patients Inferior Vena Cava Collapsibility Index (IVC CI) will be calculated as: [(IVC diameter max-IVC diameter min)/IVC diameter max]×100% * IVC CI > 50% = overt hypovolemia * IVC CI < 20% = no overt hypovolemia * IVC CI of 20% to 50% will be goal For mechanically ventilated patients Inferior Vena Cava Distensibility Index (IVC DI) will be calculated as: [(IVC diameter max-IVC diameter min)/IVC diameter min]×100% IVC distensibility>18% = hypovolemia IVC distensibility<18% = no hypovolemia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients admitted in critical care with systolic Blood Pressure < 90 mmHg with any of the diagnosis as per operational definition:
- Sepsis
- Diabetic ketoacidosis
- Acute kidney injury
- Acute gastroenteritis
Key exclusion criteria (6 listed)
- Known case of right heart disease
- Known case of congestive cardiac failure
- Presence of marked ascites
- IVC could not be identified or diameter could not be measured
- Pregnant females
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 |
|---|---|---|
| Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessmentAssessment of hydration status in critically ill patient recruited to this arm will be intervened through an ultrasound guided calculation of collapsibility and distensibility index of Inferior Vena Cava. This method of intervention will be continued and repeated as needed throughout the stay of the participant in intensive care unit. | Diagnostic test | Inferior Vena Cava Collapsibility and Distensibility guided assessment arm |
Primary outcome
Within 24-hours, 7-day and 28 day mortalities
Time frame: Mortalities will be assessed and recorded within 24hour, then day 7 up to 28th day.
Death of participant will be considered mortality.
Cumulative fluid balance
Time frame: At 6 hours of enrolment of participant
A difference of total amount of fluids given both intravenously and through oral rout to a total amount of urine output or fluid removed during dialysis, calculated in milliliter (ml) will be taken as cumulative fluid balance.
Change in Sequential Organ Failure Assessment score(Δ SOFA)
Time frame: At 24 hours of enrolment
A difference will be noted in initial Sequential Organ Failure Assessment score ( from 0 up to 24) to score at 24 hours .A positive difference in score will be considered as improvement and a negative difference will be considered as worsening in outcomes. Values for cumulative SOFA scores as well as individual organ SOFA scores for hepatic, neurological, cardiovascular, renal, coagulopathy and respiratory will be analyzed.
5 secondary outcomes
Days in Intensive Care Unit (ICU)
Time frame: ICU days up to 28 day
Days on mechanical ventilation
Time frame: Days in which participant will be on mechanical ventilation up to 28 days
Change in lactic acid levels in septic patient
Time frame: At 6 hours of enrolment of participant
Change in Blood Sugar random (BSR) levels in patients with diabetic ketoacidosis
Time frame: At 6 hours of enrolment of participant
Change in Power of hydrogen (PH) in patients with sepsis and diabetic ketoacidosis
Time frame: At 6 hours of enrolment of participant
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 5 Dec 2024.
- Results publication: PubMed 35379765Kashani K, Omer T, Shaw AD. The Intensivist's Perspective of Shock, Volume Management, and Hemodynamic Monitoring. Clin J Am Soc Nephrol. 2022 May;17(5):706-716. doi: 10.2215/CJN.14191021. Epub 2022 Apr 4.
- Results publication: PubMed 39298556Basmaji J, Arntfield R, Desai K, Lau VI, Lewis K, Rochwerg B, Fiorini K, Honarmand K, Slessarev M, Leligdowicz A, Park B, Prager R, Wong MYS, Jones PM, Ball IM, Orozco N, Meade M, Thabane L, Guyatt G. The Impact of Point-of-Care Ultrasound-Guided Resuscitation on Clinical Outcomes in Patients With Shock: A Systematic Review and Meta-Analysis. Crit Care Med. 2024 Nov 1;52(11):1661-1673. doi: 10.1097/CCM.0000000000006399. Epub 2024 Sep 18.
- Results publication: PubMed 33856325Musikatavorn K, Plitawanon P, Lumlertgul S, Narajeenron K, Rojanasarntikul D, Tarapan T, Saoraya J. Randomized Controlled Trial of Ultrasound-guided Fluid Resuscitation of Sepsis-Induced Hypoperfusion and Septic Shock. West J Emerg Med. 2021 Feb 10;22(2):369-378. doi: 10.5811/westjem.2020.11.48571.
- Results publication: PubMed 35302241Spiliotaki E, Saranteas T, Moschovaki N, Panagouli K, Pistioli E, Kitsinelis V, Briasoulis P, Papadimos T. Inferior vena cava ultrasonography in the assessment of intravascular volume status and fluid responsiveness in the emergency department and intensive care unit: A critical analysis review. J Clin Ultrasound. 2022 Jun;50(5):733-744. doi: 10.1002/jcu.23194. Epub 2022 Mar 18.
- Results publication: PubMed 37915939Kaptein EM, Kaptein MJ. Inferior vena cava ultrasound and other techniques for assessment of intravascular and extravascular volume: an update. Clin Kidney J. 2023 Jun 29;16(11):1861-1877. doi: 10.1093/ckj/sfad156. eCollection 2023 Nov.
- The Intensivist's Perspective of Shock, Volume Management, and Hemodynamic MonitoringLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share Individual patient data.
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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.
Shamim Kausar, EDIC,FCPS principal investigator
Jinnah Post Graduate and Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment in people with Sepsis and Acute Renal Failure, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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 6 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 5 Dec 2024. 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 Pakistan. 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?
Within 24-hours, 7-day and 28 day mortalities (time frame: Mortalities will be assessed and recorded within 24hour, then day 7 up to 28th day.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06516692, which also lists 5 linked publications.
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 5 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.