Clinical trial NCT01862588: Renal Resistive Index and Cardiac Output Changes During Resuscitation Predict the Occurrence of Acute Kidney Injury in Septic Shock Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Acute Kidney Injury
Septic Shock
Keywords: septic shock
acute kidney injury
renal resistive index
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critical ill patients diagnosed with septic shock who required a fluid resuscitation.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 7 days AKI occurrence
timeFrame: 7 days
Secondary outcomes:
measure: eGFR
timeFrame: until 6 hours after enrollment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Zhongda Hospital of Southeast University
state: Jiangsu
Study officials:
References:
citation: Luo JC, Qiu XH, Pan C, Xie JF, Yu T, Liu L, Yang Y, Qiu HB. Increased cardiac index attenuates septic acute kidney injury: a prospective observational study. BMC Anesthesiol. 2015 Mar 1;15:22. doi: 10.1186/s12871-015-0005-0. eCollection 2015.