NCT01862588

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

May 13, 2013

Last Update Submit

January 14, 2014

Conditions

Keywords

septic shockacute kidney injuryrenal resistive index

Outcome Measures

Primary Outcomes (1)

  • 7 days AKI occurrence

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

    7 days

Secondary Outcomes (1)

  • eGFR

    until 6 hours after enrollment

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critical ill patients diagnosed with septic shock who required a fluid resuscitation.

You may qualify if:

  • ≥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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Zhongda Hospital of Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

For every enrolled patient,we will collect 5ml blood plasma for renal function examination, and this point will fully informed and approved by the Ethic Committee.

MeSH Terms

Conditions

Critical IllnessAcute Kidney InjuryShock, Septic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSepsisInfectionsSystemic Inflammatory Response SyndromeInflammationShock

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 24, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations