Renal Resistive Index and Cardiac Output Changes During Resuscitation Predict the Occurrence of Acute Kidney Injury in Septic Shock Patients

• Conditions: Septic Shock; Critically Ill; Acute Kidney Injury

• Registration Number: NCT01862588
• Lead Sponsor: Zhongda Hospital

Brief Summary

Record the renal resistive index and hemodynamic parameters ( record the cardiac output and stroke volume if the patient's next to kin agree to undertake a PiCCO monitoring ) before and after resuscitation for severe sepsis or septic shock patients, to determine whether the changes of resistive index or hemodynamic parameters, especially the cardiac output can be a better parameter to predict AKI

Detailed Description

* Purpose: To examine whether the resuscitation-induced changes of renal resistive index or hemodynamic parameters has the superiority as a valid tool to evaluate the renal perfusion improvement and whether the changes can better predict AKI occurrence in severe sepsis or septic shock patients.

* Methods: Measure the renal resistive index and take record of hemodynamic parameters (use a PiCCO monitoring to measure cardiac output if the patient's next to kin agree to undertake such a catheter ) before and after successful resuscitation for severe sepsis or septic shock patients, followup to determine the occurrence of AKI and mortality.

* Hypothesis: The changes of resistive index or cardiac output during shock resuscitation may be a better parameter to evaluate renal perfusion and predict AKI, and may have a better value to guide renal protective therapy in septic shock.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-24
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ≥18 years, Sex unlimited
• Arriving ICU in 6 hours and diagnosed with severe sepsis or septic shock
• Physician in charge decide that an aggressive fluid resuscitation was in order

Exclusion Criteria

• Pregnancy, Age <18 years
• Ongoing recovery from AKI
• Known end-stage renal disease or chronic kidney disease(glomerular filtration rate <30mL/min/1.73m2)
• Known other causes of shock morbidly
• conditions known to modify RRI, such as renal-artery stenosis, intra-abdominal hypertension(>35cmH2O)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
7 days AKI occurrence	7 days	Follow up to determine the occurrence of AKI in 7 days after inclusion.

Secondary Outcome Measures

Name	Time	Method
eGFR	until 6 hours after enrollment	eGFR when enrolled and 6 hours after enrollment.The 2012 SSC guideline for severe sepsis and septic shock recommend to achieve some six-hour resuscitation goals.So we collect 5ml blood and 2 hrs urine when enrolled(at this time, initiate large amount of fluid resuscitation,which is so called "before resuscitation"). At 6hrs after enrolled,collect another 5ml blood and 2 hrs urine.Glomerular filtration rate (GFR) describes the flow rate of filtered fluid through the kidney. eGFR is Creatinine-based approximations of GFR. We project to use the "Urine Creatinine concentration×Urine Flow Rate/Plasma Creatinine Concentration" formula to calculate the eGFR (collected two hours urine, and examine the plasma and urine creatinine in the middle of the two hours). The lowest plasma creatinine value in the 3 months preceding inclusion was taken as the baseline value, therefore use the value to calculate baseline eGFR by CKD-EPI formula.

Trial Locations

Locations (1)

Affiliated Zhongda Hospital of Southeast University; 🇨🇳 Nanjing, Jiangsu, China