Critically IllCORRINCT01862588
Renal Resistive Index and Cardiac Output Changes During Resuscitation Predict the Occurrence of Acute Kidney Injury in Septic Shock Patients
An observational study of Critically Ill and Acute Kidney Injury, run by Zhongda Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critically Ill, Acute Kidney Injury, Septic Shock
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical ill patients diagnosed with septic shock who required a fluid resuscitation.
Who may be able to join
- ≥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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Zhongda Hospital of Southeast University
Nanjing, Jiangsu, 210009
Xiaohua Qiu, MD, 0086-025 83262553, xiaohua0917@163.com
Jingchao Luo, MD, 0086-13605172811, sucapter@163.com
About this study
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
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
Read the 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.
- Conditions
- Critically Ill, Acute Kidney Injury, Septic Shock
- Keywords
- septic shock, acute kidney injury, renal resistive index
- Medical subject headings
- Critical Illness, Acute Kidney Injury, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
7 days AKI occurrence
Follow up to determine the occurrence of AKI in 7 days after inclusion.
Measured: 7 days
Secondary outcomes (1)
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.
Measured: until 6 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Qiu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862588
- Sponsor's protocol ID
- 201314159
- Acronym
- CORRI
- Status last verified
- Jan 2014
- First submitted
- 13 May 2013
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25745357
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01862588
- Acronym / sponsor ID
- CORRI / 201314159
- Conditions
- Critically Ill, Acute Kidney Injury, Septic Shock
- Keywords
- septic shock, acute kidney injury, renal resistive index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical ill patients diagnosed with septic shock who required a fluid resuscitation.
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
7 days AKI occurrence
Time frame: 7 days
Follow up to determine the occurrence of AKI in 7 days after inclusion.
1 secondary outcome
eGFR
Time frame: until 6 hours after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Derived from this study: PubMed 25745357Luo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Acute Kidney Injury, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Qiu, MD (0086-025-83262553, xiaohua0917@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7 days AKI occurrence (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2014.