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

Acute Kidney Injury Clinical Trial

— CORRI  

Official title:

Clinical Study of Renal Resistive Index and Hemodynamic Parameters Changes Caused by Fluid Resuscitation to Predict the Occurrence of Acute Kidney Injury in Septic Shock Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01862588
• Other study ID #: 201314159
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2013
• Last updated: January 14, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Zhongda Hospital
• Contact: Xiaohua Qiu, MD
• Phone: 0086-025-83262553
• Email: xiaohua0917[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Critically Ill
• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
China	Affiliated Zhongda Hospital of Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7 days AKI occurrence	Follow up to determine the occurrence of AKI in 7 days after inclusion.	7 days	Yes
Secondary	eGFR	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.	until 6 hours after enrollment	Yes