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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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
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| 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%
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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Within 24-hours, 7-day and 28 day mortalities | Death of participant will be considered mortality. | 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. | 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. | At 24 hours of enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Days in Intensive Care Unit (ICU) | Total ICU stay in days will be noted | ICU days up to 28 day |
| Days on mechanical ventilation | This outcome will be measured for the participants who will be mechanically ventilated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shamim Kausar, EDIC,FCPS | Jinnah Post Graduate and Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinnah Post graduate Medical Centre | Karachi | Sindh | 71550 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35379765 | Result | 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. | |
| 39298556 | Result | Basmaji 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. |
| Label | URL |
|---|---|
| The Intensivist's Perspective of Shock, Volume Management, and Hemodynamic Monitoring | View source |
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No plan to share Individual patient data.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D058186 | Acute Kidney Injury |
| D016883 | Diabetic Ketoacidosis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 | 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 | 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. | At 6 hours of enrolment of participant |
| 33856325 | Result | Musikatavorn 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. |
| 35302241 | Result | Spiliotaki 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. |
| 37915939 | Result | Kaptein 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |