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NCT Number: NCT06516692

Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah Post graduate Medical Centre

Karachi, Sindh, 71550, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Days in Intensive Care Unit (ICU)

    Time frame: ICU days up to 28 day

    Total ICU stay in days will be noted

  2. 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.

  3. 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

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Jinnah Postgraduate Medical Centre

Other Gov

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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