Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.

December 3, 2024 updated by: Jinnah Postgraduate Medical Centre

(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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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,

  1. Within 24 hours 7 day and 28 day mortality
  2. Change in Sequential Organ failure Assessment (ΔSOFA) score from baseline to 24 hours after fluid management.
  3. Cumulative fluid balance at 6 hours of fluid management
  4. Days on mechanical ventilation
  5. Days in Intensive Care Unit (ICU)
  6. Change in lactic acid levels in sepsis sub group
  7. Change in Blood sugar Random (BSR) in Diabetic ketoacidosis (DKA) sub group
  8. Change in Power of Hydrogen (PH) in septic and diabetic ketoacidosis sub group of participant

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 71550
        • Jinnah Post graduate Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Clinical Parameters guided assessment arm

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
Experimental: Inferior Vena Cava Collapsibility and Distensibility guided assessment arm

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Mortalities will be assessed and recorded within 24hour, then day 7 up to 28th day.
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.
At 6 hours of enrolment of participant
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.
At 24 hours of enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days in Intensive Care Unit (ICU)
Time Frame: ICU days up to 28 day
Total ICU stay in days will be noted
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
This outcome will be measured for the participants who will be mechanically ventilated.
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
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
Time Frame: At 6 hours of enrolment of participant
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
Time Frame: At 6 hours of enrolment of participant
This outcome will be calculated as difference of values from time of enrolment to 6 hours.
At 6 hours of enrolment of participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Postgraduate Medical Centre

Investigators

  • Principal Investigator: Shamim Kausar, EDIC,FCPS, Jinnah Post Graduate and Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO.F.2-81/2023-GENL/64/JPMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share Individual patient data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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