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Clinical Trials/NCT02338895
NCT02338895UnknownNot Applicable

An Ultrasound- Guided Algorithm for the Management of Oliguria in Septic Shock

King Faisal Specialist Hospital & Research Center1 site in 1 country40 target enrollmentStarted: September 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Locations
1
Primary Endpoint
acute Kidney Injury

Study Overview

Brief Summary

Acute Kidney Injury (AKI) develops in 88% to 30% of critically ill patients admitted to an intensive care unit and is a strong predictor of mortality.Therefore any management strategy that prevents progression of renal risk to injury or failure has the potential to improve outcomes in these patients.Conventional management of acute oliguria in shock has been to blindly 'push' fluids to improve renal perfusion or to give loop diuretics once fluid loading has been considered as accomplished. However both volume overload and 'blind' attempts at fluid removal can worsen renal injury and have been associated with higher mortality by venous overcongestion and inappropriate hypovolemia. It seems reasonable to assume that a bedside test to visualize volume status and renal perfusion may assist in improving outcomes in this cohort.The investigators developed a goal-directed ultrasonographic protocol to provide immediate hemodynamic information in acutely oliguric patients with shock as well as a management algorithm for guiding therapy. The investigators incorporated IVC diameter measurement, respiratory variation and response to a passive leg raise to assess whether further fluid boluses were required and a measurement of renal perfusion to determine whether diuretics or renal replacement therapy were indicated. The investigators aim to measure the effects of this management protocol on the rates of AKI in the study participants as compared to prior to the implementation of the protocol.The study design is a prospective, observational. Since this is a proof of concept study, the projected sample size is 40 patients. An interim analysis will be carried out after 20 patients are enrolled and a further 20 will be enrolled as necessary

Detailed Description

BACKGROUND & INTRODUCTION:

Acute Kidney Injury (AKI) develops in 88% to 30% of critically ill patients admitted to an intensive care unit. While AKI of any severity is a strong predictor of mortality (1-4), both morbidity and mortality increase with increasing severity of renal injury(2). Therefore any management strategy that prevents progression of renal risk to injury or failure has the potential to improve outcomes in these patients.

Conventional management of acute oliguria in shock has been to blindly 'push' fluids to improve renal perfusion or to give loop diuretics once fluid loading has been considered as accomplished. However both volume overload and 'blind' attempts at fluid removal can worsen renal injury and have been associated with higher mortality by venous overcongestion (5) and inappropriate hypovolemia (6-8). It seems reasonable to assume that a bedside test to visualize volume status and renal perfusion may assist in improving outcomes in this cohort. Intensive care unit (ICU) bedside ultrasound has become the standard of care for critically ill patients(9-18). In patients with shock, inferior vena cava ultrasonographic evaluation for 'fluid responsiveness' is routinely used to direct resuscitation (19-21) by direct measurement of IVC diameter and respiratory variation or by the response to a noninvasive fluid bolus from a passive leg raise (22). Doppler ultrasound of intrarenal vessels has also been described as a tool to assess renal perfusion (23-27).

The investigators developed a goal-directed ultrasonographic protocol to provide immediate hemodynamic information in acutely oliguric patients with shock as well as a management algorithm for guiding therapy. The investigators incorporated IVC diameter measurement, respiratory variation and response to a passive leg raise to assess whether further fluid boluses were required and a measurement of renal perfusion to determine whether diuretics or renal replacement therapy were indicated.

The objectives are to measure the effects of this management protocol on the rates of AKI in the study participants as compared to prior to the implementation of the protocol.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
14 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Critically ill, adult patients AND with acute oliguric renal failure AND within 6 hours of presentation

Exclusion Criteria

  • i. Patients with pre-existing chronic renal failure ii. Patients on renal replacement therapy/ Dialysis iii. Patients with poor sonographic windows

Outcomes

Primary Outcomes

acute Kidney Injury

Time Frame: 28 days

Secondary Outcomes

  • mortality(28 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nawal Salahuddin

Consultant Physician

King Faisal Specialist Hospital & Research Center

Study Sites (1)

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