Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.

NCT06516692 | Completed DMC FDA Device

• 1 other identifier: NO.F.2-81/2023-GENL/64/JPMC
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis; Acute Renal Failure; Acute Gastroenteritis; Diabetic Ketoacidosis

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Days in Intensive Care Unit (ICU)

  ICU days up to 28 day

• Days on mechanical ventilation

  Days in which participant will be on mechanical ventilation up to 28 days

• Change in lactic acid levels in septic patient

  At 6 hours of enrolment of participant

• Change in Blood Sugar random (BSR) levels in patients with diabetic ketoacidosis

  At 6 hours of enrolment of participant

• Change in Power of hydrogen (PH) in patients with sepsis and diabetic ketoacidosis

  At 6 hours of enrolment of participant

Study Arms (2)

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

Diagnostic Test: Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment

Interventions

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.

Inferior Vena Cava Collapsibility and Distensibility guided assessment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Jinnah Post graduate Medical Centre

Karachi, Sindh, 71550, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 35379765 BACKGROUND

• 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.

  PMID: 39298556 BACKGROUND

• 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.

  PMID: 33856325 BACKGROUND

• 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.

  PMID: 35302241 BACKGROUND

• 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.

  PMID: 37915939 BACKGROUND

Related Links

• The Intensivist's Perspective of Shock, Volume Management, and Hemodynamic Monitoring

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury; Diabetic Ketoacidosis

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Shamim Kausar, EDIC,FCPS

  Jinnah Post Graduate and Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 24, 2024
• Study Start: August 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)