Intraoperative ComplicationsPhase 2NCT03697330
Liberal Versus Restrictive Fluid Protocols in Adults
A Phase 2 study testing Ringer lactate in people with Intraoperative Complications, run by Assiut University at 1 site in Egypt.
Trial summary
The term acute kidney injury (AKI) is used to describe a rapid deterioration (hours to days) of renal function. This rapid deterioration leads to accumulation of plasma waste products, such as urea and creatinine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Complications
- What is being tested?
- Ringer lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2018to 30 Jun 2019
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18-50 years scheduled for unilateral orthopedic lower limb surgery
- ASA I and II
- Gender: both
Who cannot join
- Patient refusal
- Hypersensitivity to any local anesthetics
- Bleeding diathesis
- Skin lesions or wounds at the puncture site of the proposed block
- Psychiatric disorders
- Failed intra-thecal anesthesia or inadequate sensory block for surgery requiring conversion to general anesthesia
Show all 13Show fewer
- Pregnancy
- Chronic kidney disease
- Diabetes mellitus, chronic heart, lung or liver disease
- Hemodynamic instability (intra and/or post-operative)
- Burn injury, usage of x-ray contrast and sepsis.
- Morbid obesity
- Corticosteroid usage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liberal Versus Restrictive Fluid Protocols in Adults Patients Undergoing Unilateral Orthopedic Lower Limb Surgery Under Spinal Anesthesia
The term acute kidney injury (AKI) is used to describe a rapid deterioration (hours to days) of renal function. This rapid deterioration leads to accumulation of plasma waste products, such as urea and creatinine.
Accumulation of urea and other nitrogen-containing substances in the blood stream lead to a number of symptoms, such as fatigue, loss of appetite, headache, nausea and vomiting. Marked increases in the potassium level can lead to irregularities in the heartbeat, which can be severe and life-threatening. Fluid balance is frequently affected, though blood pressure can be high, low or normal. Pain in the flanks may be encountered in some conditions (such as thrombosis of the renal blood vessels or inflammation of the kidney); this is the result of stretching of the fibrous tissue capsule surrounding the kidney.
Read more
Perioperative AKI is a leading cause of morbidity and mortality; It is associated with increased risk of sepsis, anemia, coagulopathy, and mechanical ventilation.
The first publication of consensus criteria for AKI was published in 2004. The system was named RIFLE (risk, injury, failure, loss of kidney function and end-stage renal failure) and used sCr or urine output to define AKI.
Later, in 2007, a modified definition of the RIFLE criteria was published by the Acute Kidney Injury Network (AKIN) .Although the AKIN criteria evolved from the RIFLE criteria, a major advance was the understanding that even small changes in sCr concentrations are associated with increased morbidity and mortality. The AKIN criteria allowed definition of AKI even without knowledge of baseline sCr.
In 2012, a clinical practice guideline of AKI was proposed by the Kidney Disease Improving Global Outcomes (KDIGO) Foundation. The guideline included a comprehensive review of AKI definition, risk assessment, diagnosis, prevention, treatment and renal replacement therapy.
A common practice to maintain effective blood volume and thus kidney perfusion is intravenous (I.V.) hydration. Correcting hypovolemia is an essential perioperative hemodynamic goal and appropriate hydration is considered important for the avoidance of AKI.
Perioperative fluid therapy has been studied extensively, but the optimal strategy remains controversial and uncertain. Much of the current debate surrounds the type of fluids administered (colloid versus crystalloid), the total volume administered (restrictive versus liberal), and whether the administration of fluids should be guided by hemodynamic goals (goal directed [GD] versus not goal directed).
Administering a large amount of I.V. fluid in the perioperative period is a common clinical practice. Although fluid loading may expand intravascular space, improve organ perfusion or tissue oxygenation and reduce minor postoperative complications in laparoscopic surgery, excessive fluid may also increase some perioperative complications.
Intraoperative urine output is often monitored but rarely responds to fluid administration. Clearance of fluid during general anesthesia is only a small fraction of that observed in conscious volunteers. Infusion of crystalloids during anesthesia shows reduced clearance and slower distribution such that intraoperative oliguria may not reflect fluid status or predict future AKI.
Given that liberal fluid administration can be correlated with worse postoperative outcome, the recommendation to maintain urine output of at least 0.5 ml/kg/h should be considered.
Read the detailed description
Prior to surgery, all patients will undergo pre-anesthetic checkup including detailed history, physical, systemic examination, height and weight of the patient. All patients will be investigated for exclusion of any of the above mentioned contraindications. Routine preoperative laboratory investigations as complete blood count, grouping, coagulation profile, electrolytes and preoperative baseline serum creatinine will be measured. Patients should have low molecular weight heparin administered till the evening prior to daytime trauma lists. This precaution allows for an appropriate window of time to minimize the risk of bleeding related to neuraxial anesthesia. All patients will be kept nil per mouth 6 h for solids and 2 h for water and clear liquids.
Preparation of the patient and conduct of anesthesia:
Written consent and emergency resuscitation equipments including airway devices, advanced life support drugs for LA toxicity and intraoperative adverse events will be available. All patients will be anesthetized by the same team of anesthesiologists and operated upon by the same surgeon who will be unaware of the study medications.
After arriving at the operative room, the pulse oximetry, electrocardiography, temperature probe and non-invasive blood pressure monitor will be applied. A large bore I.V. cannula (18 gauge) will be inserted.
Spinal anesthesia will be used for all patients. Under aseptic technique and local skin infiltration with 1% lidocaine, spinal anesthesia will be performed at the L3-4 or L4-5 spinal interspace by 25 gauge spinal needle. After successful cerebrospinal fluid recognition, 10 mg heavy bupivacaine 0.5% mixed with 25 ug fentanyl will be injected into the subarachnoid space. Then the spinal needle will be removed and the patients will be positioned carefully to the suitable position. Once adequate anesthesia to at least T10 dermatome achieved, the operation will be allowed to be started. Supplemental oxygen will be administered via face mask at flow rate between 5 and 8 L/min. Management of the patients will be performed by another anesthesiologist unaware about the used protocol. Vital signs including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressur (MBP) and arterial oxygen saturation (SpO2) will be recorded as baseline 5 min before conduction of spinal anesthesia, immediately after conduction of anesthesia then every 5 min till end of surgery. The level of sensory block will be assessed before beginning of surgery using an ice cube. Urinary catheter will be inserted for all patients. Hypotension defined as decrease in mean blood pressure (MAP) to more than 20% of baseline values will be treated with a 3 mg I.V. bolus of ephedrine repeated every 2 min if hypotension persists. If hypotension persists after 30 mg ephedrine, additional amounts of Ringer's lactate (5ml/ kg) will be infused through the 18 gauge cannula.
Patients will be asked to report any intraoperative pain or discomfort using visual analog scale (VAS) of 0-10.
After finishing surgery, patients will be transferred to the surgical ICU where they will be monitored by an intensivist who will be blinded to the study group.
Once the patients sent to ICU, both groups will receive 1.5 ml/kg/h of Ringer's lactate solution as fluid maintenance. Follow-up will be done for 5 days postoperatively using:
- Monitors for HR, SBP, DBP, MBP, SpO2 , respiratory rate and recovery time of motor blockade (up to Bromage 2)
- Analgesia: paracetamol 1 gm/ 6 hours regularly
- Supplemental oxygen will be provided in the first 24 hours after the operation if arterial oxygen saturation < 94%.
- Early mobilization: will improve oxygenation and respiratory function.
- Fluid balance as hypovolemia is common postoperatively and oral fluid intake should be encouraged over the intravenous route.
- Urinary tract infections (UTI): is common and urinary catheters should be removed as soon as possible to reduce the risk of infection and urine output will be collected and calculated as [after 12 hours, on day 2 (in 24 hours), 3 (in 24 hours), and 5 (in 24 hours after surgery]
- Routine laboratory investigations as CBC, coagulation profile, electrolytes, blood urea and serum creatinine.
- Symptoms suggestive of AKI: fatigue, loss of appetite, headache, nausea, vomiting and pain in the flanks Patients will be discharged from ICU when hemodynamics are stable and laboratory investigations are within normal.
- Conditions
- Intraoperative Complications
- Being tested
- Ringer lactate
- Keywords
- liberal, restrictive, fluid, RIFLE
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer lactateDrug
Also called lactated ringers solution
Randomization will be done using computer generated table of random numbers in a 1:1 ratio and will be conducted using sequentially numbered, opaque and sealed envelope. The trial will be planned that neither the doctors (investigators) nor the patients will be aware of the group allocation and amount of fluid received. Intraoperative and postoperative data collections will be achieved by the same blinded anesthiologist.
Patients will be randomly allocated into two groups:
Group L: 40 patients who will be subjected to ''liberal" approach of intraoperative 18-20 ml/kg/h of Ringer's lactate starting from conduction of spinal anesthesia.
Group R: 40 patients who will be subjected to ''restrictive" approach of intraoperative 4-6 ml/kg/h of Ringer's lactate starting from conduction of spinal anesthesia.
Blood loss will be replaced if more than 500 ml in a ratio of 3 ml crystalloid: 1 ml blood.
| Study group | Role | What they receive |
|---|---|---|
| Ringer's lactate 18-20 ml/kg | Active comparator | Patients will be randomly allocated into two groups of 40 patients each:
Group L:will receive 18-20 ml/kg/h of Ringer's lactate starting from conduction of spinal anesthesia. Receives: Drug: Ringer lactate |
| Ringer's lactate 4-6 ml/kg | Active comparator | Patients will be randomly allocated into two groups of 40 patients each:
Group R: will receive 4-6 ml/kg/h of Ringer's lactate starting from conduction of spinal anesthesia. Receives: Drug: Ringer lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine
mg/dl
Measured: 5 days postoperative
urine output
ml
Measured: 5 days postoperative
Secondary outcomes (3)
SBP, DBP, MAP
systolic blood pressure (mmHg) diastolic blood pressure (mmHg) mean arterial blood pressure (mmHg)
Measured: 24 hours
arterial oxygen saturation
Measured: 24 hours
heart rate
beats/min
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start28 Jan 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparing the effect of two different protocols of fluid therapy (liberal versus restrictive) in adult patients undergoing unilateral orthopedic lower limb surgery under spinal anesthesia
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAGAA AHMED HERDAN, Assiut University
- Investigators
- ragaa herdan, lecturer, Principal investigator, Assiut University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697330
- Sponsor's protocol ID
- Liberal Vs Restrictive Fluid
- Status last verified
- Jul 2019
- First submitted
- 14 Apr 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberal Versus Restrictive Fluid Protocols in Adults Patients Undergoing Unilateral Orthopedic Lower Limb Surgery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03697330
- Acronym / sponsor ID
- Liberal Vs Restrictive Fluid
- Conditions
- Intraoperative Complications
- Keywords
- liberal, restrictive, fluid, RIFLE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 5 Oct 2018 (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.
The term acute kidney injury (AKI) is used to describe a rapid deterioration (hours to days) of renal function. This rapid deterioration leads to accumulation of plasma waste products, such as urea and creatinine.
Accumulation of urea and other nitrogen-containing substances in the blood stream lead to a number of symptoms, such as fatigue, loss of appetite, headache, nausea and vomiting. Marked increases in the potassium level can lead to irregularities in the heartbeat, which can be severe and life-threatening. Fluid balance is frequently affected, though blood pressure can be high, low or normal. Pain in the flanks may be encountered in some conditions (such as thrombosis of the renal blood vessels or inflammation of the kidney); this is the result of stretching of the fibrous tissue capsule surrounding the kidney.
Perioperative AKI is a leading cause of morbidity and mortality; It is associated with increased risk of sepsis, anemia, coagulopathy, and mechanical ventilation.
The first publication of consensus criteria for AKI was published in 2004. The system was named RIFLE (risk, injury, failure, loss of kidney function and end-stage renal failure) and used sCr or urine output to define AKI.
Later, in 2007, a modified definition of the RIFLE criteria was published by the Acute Kidney Injury Network (AKIN) .Although the AKIN criteria evolved from the RIFLE criteria, a major advance was the understanding that even small changes in sCr concentrations are associated with increased morbidity and mortality. The AKIN criteria allowed definition of AKI even without knowledge of baseline sCr.
In 2012, a clinical practice guideline of AKI was proposed by the Kidney Disease Improving Global Outcomes (KDIGO) Foundation. The guideline included a comprehensive review of AKI definition, risk assessment, diagnosis, prevention, treatment and renal replacement therapy.
A common practice to maintain effective blood volume and thus kidney perfusion is intravenous (I.V.) hydration. Correcting hypovolemia is an essential perioperative hemodynamic goal and appropriate hydration is considered important for the avoidance of AKI.
Perioperative fluid therapy has been studied extensively, but the optimal strategy remains controversial and uncertain. Much of the current debate surrounds the type of fluids administered (colloid versus crystalloid), the total volume administered (restrictive versus liberal), and whether the administration of fluids should be guided by hemodynamic goals (goal directed [GD] versus not goal directed).
Administering a large amount of I.V. fluid in the perioperative period is a common clinical practice. Although fluid loading may expand intravascular space, improve organ perfusion or tissue oxygenation and reduce minor postoperative complications in laparoscopic surgery, excessive fluid may also increase some perioperative complications.
Intraoperative urine output is often monitored but rarely responds to fluid administration. Clearance of fluid during general anesthesia is only a small fraction of that observed in conscious volunteers. Infusion of crystalloids during anesthesia shows reduced clearance and slower distribution such that intraoperative oliguria may not reflect fluid status or predict future AKI.
Given that liberal fluid administration can be correlated with worse postoperative outcome, the recommendation to maintain urine output of at least 0.5 ml/kg/h should be considered.
Detailed description
Prior to surgery, all patients will undergo pre-anesthetic checkup including detailed history, physical, systemic examination, height and weight of the patient. All patients will be investigated for exclusion of any of the above mentioned contraindications. Routine preoperative laboratory investigations as complete blood count, grouping, coagulation profile, electrolytes and preoperative baseline serum creatinine will be measured. Patients should have low molecular weight heparin administered till the evening prior to daytime trauma lists. This precaution allows for an appropriate window of time to minimize the risk of bleeding related to neuraxial anesthesia. All patients will be kept nil per mouth 6 h for solids and 2 h for water and clear liquids.
Preparation of the patient and conduct of anesthesia:
Written consent and emergency resuscitation equipments including airway devices, advanced life support drugs for LA toxicity and intraoperative adverse events will be available. All patients will be anesthetized by the same team of anesthesiologists and operated upon by the same surgeon who will be unaware of the study medications.
After arriving at the operative room, the pulse oximetry, electrocardiography, temperature probe and non-invasive blood pressure monitor will be applied. A large bore I.V. cannula (18 gauge) will be inserted.
Spinal anesthesia will be used for all patients. Under aseptic technique and local skin infiltration with 1% lidocaine, spinal anesthesia will be performed at the L3-4 or L4-5 spinal interspace by 25 gauge spinal needle. After successful cerebrospinal fluid recognition, 10 mg heavy bupivacaine 0.5% mixed with 25 ug fentanyl will be injected into the subarachnoid space. Then the spinal needle will be removed and the patients will be positioned carefully to the suitable position. Once adequate anesthesia to at least T10 dermatome achieved, the operation will be allowed to be started. Supplemental oxygen will be administered via face mask at flow rate between 5 and 8 L/min. Management of the patients will be performed by another anesthesiologist unaware about the used protocol. Vital signs including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressur (MBP) and arterial oxygen saturation (SpO2) will be recorded as baseline 5 min before conduction of spinal anesthesia, immediately after conduction of anesthesia then every 5 min till end of surgery. The level of sensory block will be assessed before beginning of surgery using an ice cube. Urinary catheter will be inserted for all patients. Hypotension defined as decrease in mean blood pressure (MAP) to more than 20% of baseline values will be treated with a 3 mg I.V. bolus of ephedrine repeated every 2 min if hypotension persists. If hypotension persists after 30 mg ephedrine, additional amounts of Ringer's lactate (5ml/ kg) will be infused through the 18 gauge cannula.
Patients will be asked to report any intraoperative pain or discomfort using visual analog scale (VAS) of 0-10.
After finishing surgery, patients will be transferred to the surgical ICU where they will be monitored by an intensivist who will be blinded to the study group.
Once the patients sent to ICU, both groups will receive 1.5 ml/kg/h of Ringer's lactate solution as fluid maintenance. Follow-up will be done for 5 days postoperatively using:
- Monitors for HR, SBP, DBP, MBP, SpO2 , respiratory rate and recovery time of motor blockade (up to Bromage 2)
- Analgesia: paracetamol 1 gm/ 6 hours regularly
- Supplemental oxygen will be provided in the first 24 hours after the operation if arterial oxygen saturation < 94%.
- Early mobilization: will improve oxygenation and respiratory function.
- Fluid balance as hypovolemia is common postoperatively and oral fluid intake should be encouraged over the intravenous route.
- Urinary tract infections (UTI): is common and urinary catheters should be removed as soon as possible to reduce the risk of infection and urine output will be collected and calculated as [after 12 hours, on day 2 (in 24 hours), 3 (in 24 hours), and 5 (in 24 hours after surgery]
- Routine laboratory investigations as CBC, coagulation profile, electrolytes, blood urea and serum creatinine.
- Symptoms suggestive of AKI: fatigue, loss of appetite, headache, nausea, vomiting and pain in the flanks Patients will be discharged from ICU when hemodynamics are stable and laboratory investigations are within normal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- comparing the effect of two different protocols of fluid therapy (liberal versus restrictive) in adult patients undergoing unilateral orthopedic lower limb surgery under spinal anesthesia
| Arm | Type | Receives |
|---|---|---|
| Ringer's lactate 18-20 ml/kg | Active comparator | Drug: Ringer lactatePatients will be randomly allocated into two groups of 40 patients each: Group L:will receive 18-20 ml/kg/h of Ringer's lactate starting from conduction of spinal anesthesia. |
| Ringer's lactate 4-6 ml/kg | Active comparator | Drug: Ringer lactatePatients will be randomly allocated into two groups of 40 patients each: Group R: will receive 4-6 ml/kg/h of Ringer's lactate starting from conduction of spinal anesthesia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults 18-50 years scheduled for unilateral orthopedic lower limb surgery
- ASA I and II
- Gender: both
Key exclusion criteria (13 listed)
- Patient refusal
- Hypersensitivity to any local anesthetics
- Bleeding diathesis
- Skin lesions or wounds at the puncture site of the proposed block
- Psychiatric disorders
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 |
|---|---|---|
| Ringer lactateAlso: lactated ringers solutionRandomization will be done using computer generated table of random numbers in a 1:1 ratio and will be conducted using sequentially numbered, opaque and sealed envelope. The trial will be planned that neither the doctors (investigators) nor the patients will be aware of the group allocation and amount of fluid received. Intraoperative and postoperative data collections will be achieved by the same blinded anesthiologist. Patients will be randomly allocated into two groups: Group L: 40 patients who will be subjected to ''liberal" approach of intraoperative 18-20 ml/kg/h of Ringer's lactate starting from conduction of spinal anesthesia. Group R: 40 patients who will be subjected to ''restrictive" approach of intraoperative 4-6 ml/kg/h of Ringer's lactate starting from conduction of spinal anesthesia. Blood loss will be replaced if more than 500 ml in a ratio of 3 ml crystalloid: 1 ml blood. | Drug | Ringer's lactate 18-20 ml/kg, Ringer's lactate 4-6 ml/kg |
Primary outcome
serum creatinine
Time frame: 5 days postoperative
mg/dl
urine output
Time frame: 5 days postoperative
ml
3 secondary outcomes
SBP, DBP, MAP
Time frame: 24 hours
arterial oxygen saturation
Time frame: 24 hours
heart rate
Time frame: 24 hours
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 9 Jul 2019.
- 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.
ragaa herdan, lecturer principal investigator
Assiut University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ringer lactate in people with Intraoperative Complications, run by Assiut University at 1 site in Egypt.
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 13 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 9 Jul 2019. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
serum creatinine (time frame: 5 days postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2019.