An interventional study of Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment in Sepsis, Acute Renal Failure and Acute Gastroenteritis, sponsored by Jinnah Postgraduate Medical Centre. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Jinnah Postgraduate Medical Centre · Not applicable, Interventional, and Diagnostic
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Among 16 studies in Sepsis with a site in Pakistan — 4 open to participants now, 4 under way, 1 of them phase 3. Sepsis · Pakistan.
Among the 16 studies in Sepsis with a site in Pakistan, this one is the 7th largest by enrollment of the 13 interventional ones that give a count, is one of 3 that started in 2024, is one of 6 with no phase, and was the 11th registered.
2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.
Browse Sepsis studies →4 of the 16 studies in Sepsis with a site in Pakistan are open now. Recruiting first, the newest first:
Pakistan Institute of Medical Sciences · Sites in Pakistan
Ages 12+
KK Women's and Children's Hospital · Sites in Pakistan, China, Hong Kong and 6 more countries
Ages up to 18
Jinnah Postgraduate Medical Centre · Sites in Pakistan
Ages 18–60
Jerry Zimmerman · Sites in Pakistan, United States, Brazil and 7 more countries
Ages 1 mo–17 yrs
A study can be open while its sites in Pakistan have not opened yet or have stopped. Only those recruiting at a site in Pakistan →
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 180 is above the median of 102 across 1,166 interventional studies indexed under Sepsis.
Median enrollment 180 across the 13 interventional studies, 4,335 across the 3 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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None of the 16 has an industry lead sponsor. The 10 most frequent:
Jinnah Postgraduate Medical Centre is the lead sponsor of 38 studies on the registry; 14 are open to participants now.
Jinnah Postgraduate Medical Centre has 2 studies filed under Sepsis — fewer than ten, so there is no comparison to draw.
1 of the studies in Sepsis with a site in Pakistan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07653568Pakistan Institute of Medical SciencesA Study Comparing Carotid Doppler Ultrasound and Echocardiography to Assess Fluid Responsiveness in Septic Patients on Ventilator | 2027-01-01 |
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Among the 16 studies in Sepsis with a site in Pakistan, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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,
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Diagnostic Test: Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment
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.
Within 24-hours, 7-day and 28 day mortalities
Death of participant will be considered mortality.
Time frame: 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.
Time frame: 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.
Time frame: At 24 hours of enrolment
Days in Intensive Care Unit (ICU)
Total ICU stay in days will be noted
Time frame: ICU days up to 28 day
Days on mechanical ventilation
This outcome will be measured for the participants who will be mechanically ventilated.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At 6 hours of enrolment of participant
Plan to share: No — No plan to share Individual patient data.
Ran from Aug 2024 to primary completion in Nov 2024, 3 months.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 3 months is below that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Jinnah Postgraduate Medical Centre