Algorithm for Oliguria in Septic Shock

NCT02338895 | Unknown

• 1 other identifier: RAC # 2141039
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Kidney Injury

Keywords

acute kidney injury, oliguria,renal ultrasound

Outcome Measures

Primary Outcomes (1)

• acute Kidney Injury

  28 days

Secondary Outcomes (1)

• mortality

  28 days

Study Arms (1)

acutly oliguric patients with ultrasound

Patients with septic shock and acute oliguria that will undergo bedside ultrasonographic assessment of inferior vena caval diameter, respiratory variation and renal perfusion.

Device: Ultrasound

Interventions

Ultrasound DEVICE

Ultrasound of inferior vena cava and kidneys

acutly oliguric patients with ultrasound

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with septic shock presenting with acute oliguria

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal specialist Hospital & Research Center

Riyadh, Ar Riyadh, 11211, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Oliguria

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Iqbal Hussain, MD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

• Ashraf Nadeem, MD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iqbal Hussain, MD

CONTACT

966533215378; hiqbal@kfshrc.edu.sa

Nawal Salahuddin, MD,FCCP

CONTACT

966551948786; nsalahuddin@kfshrc.edu.sa

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician

Study Record Dates

• First Submitted: January 11, 2015
• First Posted: January 14, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

SA (1)