Femoral FracturesSNODESNCT02629250
Supernormal Oxygen Delivery for Elderly Surgical Patients
A study testing SV maximization and supernormal DO2 in people with Femoral Fractures, run by Guangzhou First People's Hospital at 1 site in China.
Trial summary
Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop more complications following major surgery. Quite a few researches have shown the benefits of goal-directed therapy (GDT) using fluid loading or inotropic agents or both to improve outcome during major surgery. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- SV maximization and supernormal DO2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Mar 2017
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adult patients scheduled for proximal femur fracture (PFF) surgery at this institution
- American Society of Anaesthesiologists (ASA) physical status of III or VI
- Two or more risk factors according to risk index of Lee
Who cannot join
- Patient age < 70 yrs
- Ongoing myocardial infarct or ischemia
- Chronic haemodialysis
- Inability to cooperate in the study
- Patient refusal
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Xiangcai Ruan, MD, PHD, 86-20-81048306, xc_ruan@hotmail.com
Xiangcai Ruan, MD, PHD
About this study
Official title: A Randomized Controlled Study of Supernormal Oxygen Delivery Goal-directed Therapy for Elderly Patients Undergoing Proximal Femoral Surgery.
Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop more complications following major surgery. Quite a few researches have shown the benefits of goal-directed therapy (GDT) using fluid loading or inotropic agents or both to improve outcome during major surgery. However there is concern that inotropic therapy for a supernormal oxygen delivery (DO2I) may lead to an increased incidence of myocardial ischemia. Even though the meta-analysis has stated that DO2I strategy could possibly reduce the incidence of cardiac complication than stroke volume optimization strategy, there are very few evidence available in the literature regarding the effect on myocardial ischemia in surgical patients, especially in non-cardiac surgical patients. This study is undertaken to test the hypothesis that an intraoperative DO2I optimization result in a decreased myocardial ischemia in the elderly high-risk surgical patients.
Read the detailed description
Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop more complications following major surgery [1]. Quite a few researches have shown the benefits of goal-directed therapy(GDT) using fluid loading or inotropic agents or both to improve outcome during major surgery [2-7]. The maintenance of adequate tissue perfusion and global oxygen delivery (DO2I) is essential to maintain adequate tissue perfusion and oxygenation in relation to increased metabolic demand during high risk surgery. However, there is concern that inotropic therapy for a supernormal oxygen delivery may lead to an increased incidence of myocardial ischemia [8]. Even though the meta-analysis has stated that DO2I optimization could possibly reduce the incidence of cardiac complication than stroke volume optimization strategy [9],there are very few evidence available in the literature regarding the effect on myocardial ischemia in surgical patients, especially in non-cardiac surgical patients. This study is undertaken to test the hypothesis that an intraoperative DO2I optimization result in a decreased myocardial ischemia in the elderly high-risk surgical patients. The investigators will conduct a prospective, randomized, controlled, double-blinded trial in seventy patients who scheduled for proximal femur surgery under General anesthesia following nerve block. Both the patients will be allocated to one of two equal groups to receive either intraoperative fluid regimen guided by SV strategy or DO2I strategy. In the control(SV) group, the patients will receive an intravenous infusion of 250 ml Ringer's lactate solution in 5 min as a fluid challenge for stroke volume maximization. In the experimental(DO2I) group, fluid and dobutamine will be given to reach a stroke volume maximization and supernormal oxygen delivery. The primary outcome is preoperative and 24h postoperative serum concentration of troponin T. Secondary outcomes include the incidence of tachycardia, arrhythmia, myocardial infarction, pneumonedema and acute heart failure, blood pressure, pulmonary infection, fluid volume, blood transfusion volume, renal function, PONV, Length of postoperative hospital stay and mortality. Data will be collected and recorded by the clinical teams who are blind to study arm allocation.
- Conditions
- Femoral Fractures
- Being tested
- SV maximization, supernormal DO2
- Keywords
- proximal femoral fracture, goal-directed therapy, myocardial injury, supernormal oxygen delivery, elders, stroke volume maximization
- Medical subject headings
- Femoral Fractures, Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SV maximizationProcedure or surgery
Also called Stroke volume maximization
When SpO2 ≥92%, mean arterial pressure (MAP) 65-100 mmHg, HR <100 bpm, Hb >8mg/dL and temperature ≥36℃, the patients will receive a 250 ml Ringer's lactate solution in 5 min as a fluid challenge for stroke volume (SV) maximization. The fluid challenge will repeat until the SV failed to increase by a factor of 10%. A reassessment on the SV maximization will be taken every 30 minutes and to restart algorithm when increased SV >10% or blood loss >250ml. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL.
supernormal DO2Procedure or surgery
Also called Stroke volume maximization + supernormal oxygen delivery
Goal directed fluid therapy is administrated as group SV maximization. Then DO2I will be assessed. If at this stage the DO2I can not be greater than 600 mL/m2 (supernormal oxygen delivery goal), then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 20 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 100 beats per minute or shows signs of cardiac ischemia.
| Study group | Role | What they receive |
|---|---|---|
| SV maximization | Placebo comparator | Goal-directed fluid therapy with stroke volume maximization. Device: The Volume-View system from Edwards Co. Receives: Procedure: SV maximization |
| supernormal DO2 | Experimental | Goal-directed fluid therapy with stroke volume maximization and supernormal oxygen delivery.
Device: The Volume-View system from Edwards Co. Receives: Procedure: supernormal DO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in concentration of troponin T at 24 hours postoperatively
Intraoperative supernormal oxygen delivery strategy will reduce the changes in concentration of troponin T at 24 hours postoperatively.
Measured: preoperative value and 24 hours postoperatively
Secondary outcomes (12)
cardiac complication up to 24 hours postoperatively
Occurrence of newly diagnosed arterial fibrilation ,severe arrhythmia,clinical signs of unstable angina, myocardial infarction,pulmonary edema or therapy-requiring cardiac failure.
Measured: up to 24 hours postoperatively
blood pressure
Invasive arterial BP(mmHg) is measured through an arterial line at the arm.episode of hypotension (30% decrease in mean BP in relation to baseline values) and hypertension (30% increase in mean BP in relation to baseline values) will be recorded.
Measured: up to 24 hours postoperatively
heart rate (HR)
HR(beats/min), bradycardia (HR < 50 beats/min), and tachycardia (HR > 100 beats/min) will be recorded at the same time as BP recording.
Measured: up to 24 hours postoperatively
SpO2
SpO2(%) and hypoxemia (SpO2 <90%) will be recorded at the same time as BP recording.
Measured: up to 24 hours postoperatively
fluid balance
amount of fluids (ml) infused, amount of fluid losses
Measured: up to 24hours after surgery
blood transfusion volume
amount of blood transfusion, amount of blood losses.
Measured: up to 24 hours postoperatively
Acute Kidney Injury
perioperative and 24h postoperative urine volume, serum creatinine, blood urea nitrogen.
Measured: up to 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV)
Postoperative Nausea and Vomiting, The incidence of PONV will be recorded using a 4-point objective score (1 = no PONV;2 = mild nausea, no vomiting; 3 = excessive nausea or vomiting;4 = vomiting ≥2 times).
Measured: 24 hours postoperatively
length of postoperative hospital stay
days from end of surgery to hospital discharge
Measured: 28 days postoperatively
mortality
mortality within 28 days after surgery
Measured: 28 days postoperatively
cardiac complication at 28 days postoperatively
Occurrence of newly diagnosed arterial fibrilation ,severe arrhythmia,clinical signs of unstable angina, myocardial infarction,pulmonary edema or therapy-requiring cardiac failure.
Measured: 28 days postoperatively
incidence of pulmonary infection
number of patients having pulmonary infection requiring intravenous antibiotic therapy
Measured: up to 28 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Femoral FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital
- Investigators
- Xiangcai Ruan, MD, PhD, Principal investigator, Guangzhou First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629250
- Sponsor's protocol ID
- GZZD-2015007
- Acronym
- SNODES
- Status last verified
- Feb 2017
- First submitted
- 9 Dec 2015
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Fowkes FG, Lunn JN, Farrow SC, Robertson IB, Samuel P. Epidemiology in anaesthesia. III: Mortality risk in patients with coexisting physical disease. Br J Anaesth. 1982 Aug;54(8):819-25. doi: 10.1093/bja/54.8.819.
PubMed 7104132Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.
PubMed 20966436Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. doi: 10.1186/cc6117.
PubMed 17822565Lobo SM, Lobo FR, Polachini CA, Patini DS, Yamamoto AE, de Oliveira NE, Serrano P, Sanches HS, Spegiorin MA, Queiroz MM, Christiano AC Jr, Savieiro EF, Alvarez PA, Teixeira SP, Cunrath GS. Prospective, randomized trial comparing fluids and dobutamine optimization of oxygen delivery in high-risk surgical patients [ISRCTN42445141]. Crit Care. 2006;10(3):R72. doi: 10.1186/cc4913. Epub 2006 May 12.
PubMed 16696864Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9.
PubMed 17925428Wilson J, Woods I, Fawcett J, Whall R, Dibb W, Morris C, McManus E. Reducing the risk of major elective surgery: randomised controlled trial of preoperative optimisation of oxygen delivery. BMJ. 1999 Apr 24;318(7191):1099-103. doi: 10.1136/bmj.318.7191.1099.
PubMed 10213716Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
PubMed 16356219Pearse RM, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett D. The incidence of myocardial injury following post-operative Goal Directed Therapy. BMC Cardiovasc Disord. 2007 Mar 19;7:10. doi: 10.1186/1471-2261-7-10.
PubMed 17371601Futier E, Vallet B. Inotropes in goal-directed therapy: do we need 'goals'? Crit Care. 2010;14(5):1001. doi: 10.1186/cc9251. Epub 2010 Sep 29.
PubMed 20920151
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Supernormal Oxygen Delivery Goal-directed Therapy for Elderly Patients Undergoing Proximal Femoral Surgery.
- ClinicalTrials.gov ID
- NCT02629250
- Acronym / sponsor ID
- SNODES / GZZD-2015007
- Conditions
- Femoral Fractures
- Keywords
- proximal femoral fracture, goal-directed therapy, myocardial injury, supernormal oxygen delivery, elders, stroke volume maximization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 14 Dec 2015 (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.
Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop more complications following major surgery. Quite a few researches have shown the benefits of goal-directed therapy (GDT) using fluid loading or inotropic agents or both to improve outcome during major surgery. However there is concern that inotropic therapy for a supernormal oxygen delivery (DO2I) may lead to an increased incidence of myocardial ischemia. Even though the meta-analysis has stated that DO2I strategy could possibly reduce the incidence of cardiac complication than stroke volume optimization strategy, there are very few evidence available in the literature regarding the effect on myocardial ischemia in surgical patients, especially in non-cardiac surgical patients. This study is undertaken to test the hypothesis that an intraoperative DO2I optimization result in a decreased myocardial ischemia in the elderly high-risk surgical patients.
Detailed description
Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop more complications following major surgery [1]. Quite a few researches have shown the benefits of goal-directed therapy(GDT) using fluid loading or inotropic agents or both to improve outcome during major surgery [2-7]. The maintenance of adequate tissue perfusion and global oxygen delivery (DO2I) is essential to maintain adequate tissue perfusion and oxygenation in relation to increased metabolic demand during high risk surgery. However, there is concern that inotropic therapy for a supernormal oxygen delivery may lead to an increased incidence of myocardial ischemia [8]. Even though the meta-analysis has stated that DO2I optimization could possibly reduce the incidence of cardiac complication than stroke volume optimization strategy [9],there are very few evidence available in the literature regarding the effect on myocardial ischemia in surgical patients, especially in non-cardiac surgical patients. This study is undertaken to test the hypothesis that an intraoperative DO2I optimization result in a decreased myocardial ischemia in the elderly high-risk surgical patients. The investigators will conduct a prospective, randomized, controlled, double-blinded trial in seventy patients who scheduled for proximal femur surgery under General anesthesia following nerve block. Both the patients will be allocated to one of two equal groups to receive either intraoperative fluid regimen guided by SV strategy or DO2I strategy. In the control(SV) group, the patients will receive an intravenous infusion of 250 ml Ringer's lactate solution in 5 min as a fluid challenge for stroke volume maximization. In the experimental(DO2I) group, fluid and dobutamine will be given to reach a stroke volume maximization and supernormal oxygen delivery. The primary outcome is preoperative and 24h postoperative serum concentration of troponin T. Secondary outcomes include the incidence of tachycardia, arrhythmia, myocardial infarction, pneumonedema and acute heart failure, blood pressure, pulmonary infection, fluid volume, blood transfusion volume, renal function, PONV, Length of postoperative hospital stay and mortality. Data will be collected and recorded by the clinical teams who are blind to study arm allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SV maximization | Placebo comparator | Procedure: SV maximizationGoal-directed fluid therapy with stroke volume maximization. Device: The Volume-View system from Edwards Co. |
| supernormal DO2 | Experimental | Procedure: supernormal DO2Goal-directed fluid therapy with stroke volume maximization and supernormal oxygen delivery. Device: The Volume-View system from Edwards Co. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Adult patients scheduled for proximal femur fracture (PFF) surgery at this institution
- American Society of Anaesthesiologists (ASA) physical status of III or VI
- Two or more risk factors according to risk index of Lee
Key exclusion criteria (5 listed)
- Patient age < 70 yrs
- Ongoing myocardial infarct or ischemia
- Chronic haemodialysis
- Inability to cooperate in the study
- Patient refusal
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 |
|---|---|---|
| SV maximizationAlso: Stroke volume maximizationWhen SpO2 ≥92%, mean arterial pressure (MAP) 65-100 mmHg, HR <100 bpm, Hb >8mg/dL and temperature ≥36℃, the patients will receive a 250 ml Ringer's lactate solution in 5 min as a fluid challenge for stroke volume (SV) maximization. The fluid challenge will repeat until the SV failed to increase by a factor of 10%. A reassessment on the SV maximization will be taken every 30 minutes and to restart algorithm when increased SV >10% or blood loss >250ml. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL. | Procedure or surgery | SV maximization |
| supernormal DO2Also: Stroke volume maximization + supernormal oxygen deliveryGoal directed fluid therapy is administrated as group SV maximization. Then DO2I will be assessed. If at this stage the DO2I can not be greater than 600 mL/m2 (supernormal oxygen delivery goal), then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 20 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 100 beats per minute or shows signs of cardiac ischemia. | Procedure or surgery | supernormal DO2 |
Primary outcome
Change from baseline in concentration of troponin T at 24 hours postoperatively
Time frame: preoperative value and 24 hours postoperatively
Intraoperative supernormal oxygen delivery strategy will reduce the changes in concentration of troponin T at 24 hours postoperatively.
12 secondary outcomes
cardiac complication up to 24 hours postoperatively
Time frame: up to 24 hours postoperatively
blood pressure
Time frame: up to 24 hours postoperatively
heart rate (HR)
Time frame: up to 24 hours postoperatively
SpO2
Time frame: up to 24 hours postoperatively
fluid balance
Time frame: up to 24hours after surgery
blood transfusion volume
Time frame: up to 24 hours postoperatively
Acute Kidney Injury
Time frame: up to 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV)
Time frame: 24 hours postoperatively
length of postoperative hospital stay
Time frame: 28 days postoperatively
mortality
Time frame: 28 days postoperatively
cardiac complication at 28 days postoperatively
Time frame: 28 days postoperatively
incidence of pulmonary infection
Time frame: up to 28 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Background: PubMed 7104132Fowkes FG, Lunn JN, Farrow SC, Robertson IB, Samuel P. Epidemiology in anaesthesia. III: Mortality risk in patients with coexisting physical disease. Br J Anaesth. 1982 Aug;54(8):819-25. doi: 10.1093/bja/54.8.819.
- Background: PubMed 20966436Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.
- Background: PubMed 17822565Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. doi: 10.1186/cc6117.
- Background: PubMed 16696864Lobo SM, Lobo FR, Polachini CA, Patini DS, Yamamoto AE, de Oliveira NE, Serrano P, Sanches HS, Spegiorin MA, Queiroz MM, Christiano AC Jr, Savieiro EF, Alvarez PA, Teixeira SP, Cunrath GS. Prospective, randomized trial comparing fluids and dobutamine optimization of oxygen delivery in high-risk surgical patients [ISRCTN42445141]. Crit Care. 2006;10(3):R72. doi: 10.1186/cc4913. Epub 2006 May 12.
- Background: PubMed 17925428Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9.
- Background: PubMed 10213716Wilson J, Woods I, Fawcett J, Whall R, Dibb W, Morris C, McManus E. Reducing the risk of major elective surgery: randomised controlled trial of preoperative optimisation of oxygen delivery. BMJ. 1999 Apr 24;318(7191):1099-103. doi: 10.1136/bmj.318.7191.1099.
- Background: PubMed 16356219Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
- Background: PubMed 17371601Pearse RM, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett D. The incidence of myocardial injury following post-operative Goal Directed Therapy. BMC Cardiovasc Disord. 2007 Mar 19;7:10. doi: 10.1186/1471-2261-7-10.
- Background: PubMed 20920151Futier E, Vallet B. Inotropes in goal-directed therapy: do we need 'goals'? Crit Care. 2010;14(5):1001. doi: 10.1186/cc9251. Epub 2010 Sep 29.
- Individual participant dataSharing planned: Undecided
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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.
Xiangcai Ruan, MD, PhD principal investigator
Guangzhou First People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SV maximization and supernormal DO2 in people with Femoral Fractures, run by Guangzhou First People's 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 16 Feb 2017. 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. Some participants in this study may receive a placebo. 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 Xiangcai Ruan, MD, PhD (+8620-81048306, xc_ruan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in concentration of troponin T at 24 hours postoperatively (time frame: preoperative value and 24 hours 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 NCT02629250, which also lists 9 linked publications.
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 16 Feb 2017.