Acute Kidney InjuryNCT03323203
Association of Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Double Valves Replacement Surgery
An observational study of Acute Kidney Injury, run by Xijing Hospital at 1 site in China.
Trial summary
To investigate the relationship of tissue oxygenation of different organs and tissue beds (e.g., a tissue bed on the arm vs. leg vs. flank tissue bed(s) and renal tissue bed, and thus can be used as a surrogate of renal tissue oxygenation monitoring. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2018to 7 Dec 2019
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are going to have double valves replacement surgery
Who may be able to join
- Written informed consent obtained
- Age ≥18 years of age
- Double valves replacement surgery with cardiopulmonary bypass (CPB)
Who cannot join
- The Trauma, deformity or abnormality sites which the sensor will be put may affect the monitoring of the data
- Preoperative renal dysfunction needs renal replacement therapy
- Emergency surgery
- Preoperative intubated patient
- Unable to cooperate with the study, i.e., mental illness, et al
- Patients with hemoglobin and anemia
Show all 9Show fewer
- Participate in other trials in the prior 3 months
- Patient refuses to participate in the study
- Patient is unfit for the study decided by reach stuff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Intraoperative Cerebral and Somatic Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Adult Patients Undergoing Double Valves Replacement Surgery
To investigate the relationship of tissue oxygenation of different organs and tissue beds (e.g., a tissue bed on the arm vs. leg vs. flank tissue bed(s) and renal tissue bed, and thus can be used as a surrogate of renal tissue oxygenation monitoring.
Read the detailed description
In this study, we will monitor tissue oxygenation of four different tissue beds including cerebral tissue (SctO2) on the forehead, and 3 somatic tissue beds monitored on the forearm (SarmO2), upper leg (SlegO2), and the renal region (SrrO2). The primary end point is AKI and the secondary end points are postoperative major non-renal complications (e.g. stroke, delirium, myocardial infraction, heart failure, new or worsening arrhythmia, mechanical ventilation > 24 hours, deep wound infection, etc.) and mortality. The associations between tissue oxygenation of different tissue beds, i.e. SctO2, SarmO2, SlegO2, and SrrO2, and AKI and non-renal outcomes will be compared to explore the tissue bed(s) whose oxygen saturation has a stronger association with the outcomes of interest. The strength of this study is to use the patient as self-control.
- Conditions
- Acute Kidney Injury
- Being tested
- FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USADevice
Tissue oxygenation was monitored using a tissue oximeter based on near-infrared spectroscopy (FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA). The oximeter had four cables with each cable connected to an adhesive probe.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute kidney injury (AKI)
AKI is defined as any of the following (Not Graded):
- K Increase in serum creatinine (SCr) by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or
- K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or
- K Urine volume o0.5 ml/kg/h for 6 hours.AKI is defined as any of the following (Not Graded):
- K Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or
- K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or
- K Urine volume o0.5 ml/kg/h for 6 hours.
AKI is defined as any of the following (Not graded):Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume less than 0.5 ml/kg/h for 6 hours.
Measured: Seven days postoperatively
Secondary outcomes (4)
Length of mechanical ventilation
Time between intubation and extubation
Measured: Postoperative day 0-day 7
Length of ICU stay
Days between end of operation and departure of ICU
Measured: Postoperative day 0-day 7
Length of hospital stay
Days between end of operation and hospital discharge
Measured: Postoperative day 0-day 30
Adverse events in 30 days
Clinical events since hospital discharge
Measured: Postoperative day 0-day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start4 Jan 2018
- Primary completion7 Dec 2019
- Study completion7 Dec 2019
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 Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chonglei, Xijing Hospital
- Investigators
- Hailong Dong, PhD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323203
- Sponsor's protocol ID
- KY20172070-1
- Status last verified
- Dec 2020
- First submitted
- 24 Oct 2017
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang H, Zhang T, Hou L, Zhao J, Fan Q, Wang L, Lu Z, Dong H, Lei C. Association of intraoperative cerebral and somatic tissue oxygen saturation with postoperative acute kidney injury in adult patients undergoing multiple valve surgery. BMC Anesthesiol. 2023 Sep 19;23(1):319. doi: 10.1186/s12871-023-02279-7.
PubMed 37726660
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Intraoperative Cerebral and Somatic Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Adult Patients Undergoing Double Valves Replacement Surgery
- ClinicalTrials.gov ID
- NCT03323203
- Acronym / sponsor ID
- KY20172070-1
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 7 Dec 2019 (actual)
- Study completion
- 7 Dec 2019 (actual)
- First posted
- 26 Oct 2017 (actual)
- 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.
To investigate the relationship of tissue oxygenation of different organs and tissue beds (e.g., a tissue bed on the arm vs. leg vs. flank tissue bed(s) and renal tissue bed, and thus can be used as a surrogate of renal tissue oxygenation monitoring.
Detailed description
In this study, we will monitor tissue oxygenation of four different tissue beds including cerebral tissue (SctO2) on the forehead, and 3 somatic tissue beds monitored on the forearm (SarmO2), upper leg (SlegO2), and the renal region (SrrO2). The primary end point is AKI and the secondary end points are postoperative major non-renal complications (e.g. stroke, delirium, myocardial infraction, heart failure, new or worsening arrhythmia, mechanical ventilation > 24 hours, deep wound infection, etc.) and mortality. The associations between tissue oxygenation of different tissue beds, i.e. SctO2, SarmO2, SlegO2, and SrrO2, and AKI and non-renal outcomes will be compared to explore the tissue bed(s) whose oxygen saturation has a stronger association with the outcomes of interest. The strength of this study is to use the patient as self-control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are going to have double valves replacement surgery
Key inclusion criteria (3 listed)
- Written informed consent obtained
- Age ≥18 years of age
- Double valves replacement surgery with cardiopulmonary bypass (CPB)
Key exclusion criteria (9 listed)
- The Trauma, deformity or abnormality sites which the sensor will be put may affect the monitoring of the data
- Preoperative renal dysfunction needs renal replacement therapy
- Emergency surgery
- Preoperative intubated patient
- Unable to cooperate with the study, i.e., mental illness, et al
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USATissue oxygenation was monitored using a tissue oximeter based on near-infrared spectroscopy (FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA). The oximeter had four cables with each cable connected to an adhesive probe. | Device | – |
Primary outcome
Postoperative acute kidney injury (AKI)
Time frame: Seven days postoperatively
AKI is defined as any of the following (Not Graded): * K Increase in serum creatinine (SCr) by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or * K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * K Urine volume o0.5 ml/kg/h for 6 hours.AKI is defined as any of the following (Not Graded): * K Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or * K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or * K Urine volume o0.5 ml/kg/h for 6 hours. AKI is defined as any of the following (Not graded):Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume less than 0.5 ml/kg/h for 6 hours.
4 secondary outcomes
Length of mechanical ventilation
Time frame: Postoperative day 0-day 7
Length of ICU stay
Time frame: Postoperative day 0-day 7
Length of hospital stay
Time frame: Postoperative day 0-day 30
Adverse events in 30 days
Time frame: Postoperative day 0-day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Derived from this study: PubMed 37726660Zhang H, Zhang T, Hou L, Zhao J, Fan Q, Wang L, Lu Z, Dong H, Lei C. Association of intraoperative cerebral and somatic tissue oxygen saturation with postoperative acute kidney injury in adult patients undergoing multiple valve surgery. BMC Anesthesiol. 2023 Sep 19;23(1):319. doi: 10.1186/s12871-023-02279-7.
- Individual participant dataSharing planned: No
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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.
Hailong Dong, PhD principal investigator
Xijing Hospital
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 Acute Kidney Injury, run by Xijing 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 9 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: finished, as of the sponsor's last update on 29 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative acute kidney injury (AKI) (time frame: Seven days postoperatively). 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 NCT03323203, 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 29 Dec 2020.