Renal InjuryPhase 2/3NCT05271253
Comparison Between Different Anaesthesia Techniques Protecting Renal Function in Children Undergoing Radicle Nephrectomy
A Phase 2/3 study testing Dexmedetomidine, bupivacaine and normal Saline in people with Renal Injury and Child, Only, run by Alexandria University at 1 site in Egypt.
Trial summary
Up to date, Renal Cell carcinomas (RCC) are one of the prevalent primary renal neoplasms affecting children \& surgical radical nephrectomy is the conventional standard of care, as the choice of non-surgical modalities like irradiation \& hormono-chemotherapy is still a subject of debate . Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Renal Injury, Child, Only
- What is being tested?
- Dexmedetomidine, bupivacaine and normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2021to 15 Jan 2022
- Phase
- Phase 2/3
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients aged 5-10 years undergoing elective RN
Who cannot join
- had history of use of α 2-agonists to treat hypertension, renal impairment (creatinine clearance < 90 ml/min), and persistent intraoperative hypotension [mean arterial blood pressure < 65 for > 20 min]. Also those with bleeding disorders and skin lesion at puncture site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Different Anaesthesia Techniques for Protecting Renal Function in Children Undergoing Radicle Nephrectomy
Up to date, Renal Cell carcinomas (RCC) are one of the prevalent primary renal neoplasms affecting children \& surgical radical nephrectomy is the conventional standard of care, as the choice of non-surgical modalities like irradiation \& hormono-chemotherapy is still a subject of debate .
Worsening of postoperative renal function is not so far from these patients who underwent nephrectomy for RCC, thus peri-operative preservation of renal function is a great challenge facing anaesthologist aiming to abolishment of postoperative acute kidney injury (AKI) development. AKI is a serious clinical diverse which increases morbidity and mortality \& enhances the risk of development of chronic kidney disease (CKD). A major advances have shown that the associations between AKI and CKD after radical nephrectomy is as high as 65 %.
Read more
For years, the diagnosis of AKI was based on ordinary kidney function tests like serum creatinine \& blood urea nitrogen, which are not efficient nowadays, as they lack specificity for renal damage, besides they are affected by many other factors apart from kidney injury.
Cystatin C is an endogenous protein with low molecular weight (13 k Da), that is freely filtrated at the glomeruli and completely reabsorbed in the proximal renal tubules. It indicates renal injury indirectly through decreased GFR .
Serum neutrophil gelatinase-associated lipocalin (NGAL) is a promising glycoprotein produced by neutrophils and epithelial cells of the proximal convoluted tubule of the nephron cells. After renal stress or nephrotoxic damage its peak plasma level is reached within 6 hrs, then remains sustained for as long as 5 days.
Dexmedetomidine (Dex.) a newer, short acting, highly selective alph-2 agonist, that possess potent analgesic, amnestic, hypnotic \& sedative properties via actions on sleep-awake cycle in the brain. Several evidences reported its possible ability for renal protection.
Caudal epidural blockade is well known efficient technique that offer postoperative analgesia for multiple surgical procedures in children. Beside hemodynamic stability, they prevent progression of acute postoperative pain to chronic pain.
The investigators hypothesized that uses of Dex infusion in a programmed fashion in children undergoing RN, could produce optimum preservation of kidney function from the concurrent perioperative insult even in a very early phase of renal stress, relative to ordinary used protocols.
Read the detailed description
Aim of the study The primary goal was comparison between different anaesthesia techniques in preservation of kidney function using early phase detectors cystatin C and NGAL. Secondary goals included measurements of creatinine clearance, serum creatinine, and urinary output. Postoperative pain assessment using visual analogue scale \& sedation score were also recorded.
- Patients and methods
After approval of the Ethical committee of faculty of Medicine, Alexandria University and obtaining an informed written consent from parents of the children included in the study, 75 patients aged 5-10 years undergoing elective RN were randomly enrolled using closed envelope method. Sample Size was calculated according to the following equation:
n=(t^2×p(1-p))/m^3
The patients were excluded if they had history of use of α 2-agonists to treat hypertension, renal impairment (creatinine clearance < 90 ml/min), and persistent intraoperative hypotension [mean arterial blood pressure < 65 for > 20 min]. Also those with bleeding disorders and skin lesion at puncture site.
Patients were randomly allocated into 3 equal groups (25 patients each): Group (C): caudal group, where caudal anaesthesia was given using 1 mL/kg dose of 0.25% bupivacaine without epinephrine. Dexmedetomidine (D) group, where Dex. (Precedex, hospira, Egypt) 0.8 μg/kg was given intravenously over 10 min as a loading dose, and then infused at a rate of 0.4 μg/kg/h; and Placebo (P) group, where normal saline instead of Dex was given in volume (ml) and rate (ml/h) calculated related to the patient's body weight. The infusions were prepared by independent participant \& were started after induction of anaesthesia and continued 24 hrs postoperatively. All children were assessed thoroughly preoperatively by history taking, physical examination \& laboratory investigations (complete blood count, coagulation profile liver function \& kidney functions.) At the night before surgery, base line value of serum creatinine, creatinine clearance were obtained using standard laboratory methods. Also, base line value of serum cystatin C and NGAL were obtained using commercially available kits (Roche Diagnostics, Mannheim, Germany) \& (Biosite Incorporated, San Diego, CA, USA) respectively by ELISA method. Establishment of method and degree of sample dilution were carried out prior to analysis according to manufacture instruction.
All children were premedicated orally with midazolam 0.5 mg/ k.g 30 minutes before induction, and they were instructed to void just before admission to the operating room.
In the operating theater, all patients were monitored throughout surgery by continuous electrocardiography, heart rate, pulse oximetry, non invasive blood pressure and end tidal capnography by (Datex-Omeda model S/5) monitor. Induction was carried out with fentanyl (1-1.5 μg/kg), and propofol (1-2 mg/kg). For facilitating endotracheal intubation, atracurium was administered at an initial dose of 0.5 mg/kg followed by boluses of 0.03 mg/kg every 20-40 min. Under aseptic technique, an arterial line and central venous catheter were inserted \& Anaesthesia was maintained using isoflurane 1-2% in oxygen, and patients were mechanically ventilated. Fentanyl and atracurium increments were given as required.
The diagnostic criteria of AKI was classified according to the Acute Kidney Injury Network (AKIN) criteria as follows: the renal function decreased rapidly within 48 hours, the s Cr level increased by ≥ 26.5 µ mol/L or ≥ 1.5 times from baseline, or urine output < 0.5 mL/kg/h for > 6 hours. Oliguria is defined as urine output < 0.5 ml/kg/h. After exclusion of catheter obstruction, patients were managed with good hydration. If it persists, 10 mg I.v Lasix was given, that could be repeated twice. If no response, nephrology consultation was ordered. At the end of surgery, muscle relaxants were reversed by neostigmine 0.04-0.06 mg/kg and atropine 0.02 mg/kg, and then the patients were extubated after returning to full muscle power. All patients were monitored in the intensive care unit for 2 days after surgery, with attention to fluid balance and urine output. Serum creatinine, creatinine clearance, Cystatin C and NGAL was assessed 24 hr before surgery, after induction of anaesthesia, 12 and 24 hrs postoperatively. Urine output was assessed intraoperatively every 1 hr and postoperatively every 6 hr in the first 24 hrs. Sedation was assessed during the first 5, 15, 30, and 60 mins in the recovery room by the investigator using a five-point sedation scale. Sedation level: Agitated = 4, Awake= 3, Drowsy= 2, Asleep= 1. A sedation score of 3 \& above was considered as unsatistisfactory while 1\&2 is considered to be satisfactory. Postoperative pain was assessed using the visual analog scale from 0-10, where 0= no pain and 10= unbearable pain.
Data management Data were fed to the computer and analyzed using IBM SPSS software package version 20.0 (Armonk, NY: IBM Corp). Quantitative data were described using range (minimum and maximum), mean, SD, and median. Significance of the obtained results was judged at the 5% level.
- Conditions
- Renal Injury, Child, Only
- Being tested
- Dexmedetomidine, bupivacaine, normal Saline
- Keywords
- radical nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called preceedex
0.5 mic /kg dexmedetomedine is injected after induction of anaesthesia.
bupivacaineDrug
0.25% bupivacaine is injected in the caudal epidural space
normal SalineDrug
Also called 0.9 % Nacl
injection of normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Group (C) | Active comparator | caudal group, where caudal anaesthesia was given using 1 mL/kg dose of 0.25% bupivacaine without epinephrine. Receives: Drug: bupivacaine |
| Group (D) | Active comparator | Dexmedetomidine (D) group, where Dex. (Precedex, hospira, Egypt) 0.8 μg/kg was given intravenously over 10 min as a loading dose, and then infused at a rate of 0.4 μg/kg/h Receives: Drug: Dexmedetomidine |
| Group (P) | Placebo comparator | Placebo (P) group, where normal saline instead of Dex was given in volume (ml) and rate (ml/h) calculated related to the patient's body weight. Receives: Drug: normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
cystatin C
Early biomarkers in detection of renal impairment
Measured: immediately after induction
cystatin C
Early biomarkers in detection of renal impairment
Measured: after 12 hours post-operatively
NGAL
Early biomarkers in detection of renal impairment
Measured: immediately after induction
NGAL
Early biomarkers in detection of renal impairment
Measured: after 12 hours post-operatively
Secondary outcomes (6)
serum creatinine
conventional renal function tests
Measured: immediately after induction
serum creatinine
conventional renal function tests
Measured: after 12 hours post-operatively
creatinine clearance
conventional renal function tests
Measured: immediately after induction
creatinine clearance
conventional renal function tests
Measured: after 12 hours post-operatively
sedation score
indicator for post operative alertness, . Sedation level: Agitated = 4, Awake= 3, Drowsy= 2, Asleep= 1. A sedation score of 3 \& above was considered as unsatisfactory while 1 \& 2 is considered to be satisfactory.
Measured: 5 mins post-operative
sedation score
indicator for post operative alertness,. Sedation level: Agitated = 4, Awake= 3, Drowsy= 2, Asleep= 1. A sedation score of 3 \& above was considered as unsatisfactory while 1 \& 2 is considered to be satisfactory.
Measured: 60 mins post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start10 Apr 2021
- Primary completion29 Nov 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InjuryStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly allocated into 3 equal groups (25 patients each): Group (C): caudal group, where caudal anaesthesia was given using 1 mL/kg dose of 0.25% bupivacaine without epinephrine. Dexmedetomidine (D) group, where Dex. (Precedex, hospira, Egypt) 0.8 μg/kg was given intravenously over 10 min as a loading dose, and then infused at a rate of 0.4 μg/kg/h; and Placebo (P) group, where normal saline instead of Dex was given in volume (ml) and rate (ml/h) calculated related to the patient's body weight.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassan S ElHoshy, lecturer, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271253
- Sponsor's protocol ID
- 0305085
- Status last verified
- Jan 2022
- First submitted
- 27 Jan 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Anaesthesia Techniques for Protecting Renal Function in Children Undergoing Radicle Nephrectomy
- ClinicalTrials.gov ID
- NCT05271253
- Acronym / sponsor ID
- 0305085
- Conditions
- Renal Injury, Child, Only
- Keywords
- radical nephrectomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 9 Mar 2022 (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.
Up to date, Renal Cell carcinomas (RCC) are one of the prevalent primary renal neoplasms affecting children \& surgical radical nephrectomy is the conventional standard of care, as the choice of non-surgical modalities like irradiation \& hormono-chemotherapy is still a subject of debate .
Worsening of postoperative renal function is not so far from these patients who underwent nephrectomy for RCC, thus peri-operative preservation of renal function is a great challenge facing anaesthologist aiming to abolishment of postoperative acute kidney injury (AKI) development. AKI is a serious clinical diverse which increases morbidity and mortality \& enhances the risk of development of chronic kidney disease (CKD). A major advances have shown that the associations between AKI and CKD after radical nephrectomy is as high as 65 %.
For years, the diagnosis of AKI was based on ordinary kidney function tests like serum creatinine \& blood urea nitrogen, which are not efficient nowadays, as they lack specificity for renal damage, besides they are affected by many other factors apart from kidney injury.
Cystatin C is an endogenous protein with low molecular weight (13 k Da), that is freely filtrated at the glomeruli and completely reabsorbed in the proximal renal tubules. It indicates renal injury indirectly through decreased GFR .
Serum neutrophil gelatinase-associated lipocalin (NGAL) is a promising glycoprotein produced by neutrophils and epithelial cells of the proximal convoluted tubule of the nephron cells. After renal stress or nephrotoxic damage its peak plasma level is reached within 6 hrs, then remains sustained for as long as 5 days.
Dexmedetomidine (Dex.) a newer, short acting, highly selective alph-2 agonist, that possess potent analgesic, amnestic, hypnotic \& sedative properties via actions on sleep-awake cycle in the brain. Several evidences reported its possible ability for renal protection.
Caudal epidural blockade is well known efficient technique that offer postoperative analgesia for multiple surgical procedures in children. Beside hemodynamic stability, they prevent progression of acute postoperative pain to chronic pain.
The investigators hypothesized that uses of Dex infusion in a programmed fashion in children undergoing RN, could produce optimum preservation of kidney function from the concurrent perioperative insult even in a very early phase of renal stress, relative to ordinary used protocols.
Detailed description
Aim of the study The primary goal was comparison between different anaesthesia techniques in preservation of kidney function using early phase detectors cystatin C and NGAL. Secondary goals included measurements of creatinine clearance, serum creatinine, and urinary output. Postoperative pain assessment using visual analogue scale \& sedation score were also recorded.
- Patients and methods
After approval of the Ethical committee of faculty of Medicine, Alexandria University and obtaining an informed written consent from parents of the children included in the study, 75 patients aged 5-10 years undergoing elective RN were randomly enrolled using closed envelope method. Sample Size was calculated according to the following equation:
n=(t^2×p(1-p))/m^3
The patients were excluded if they had history of use of α 2-agonists to treat hypertension, renal impairment (creatinine clearance < 90 ml/min), and persistent intraoperative hypotension [mean arterial blood pressure < 65 for > 20 min]. Also those with bleeding disorders and skin lesion at puncture site.
Patients were randomly allocated into 3 equal groups (25 patients each): Group (C): caudal group, where caudal anaesthesia was given using 1 mL/kg dose of 0.25% bupivacaine without epinephrine. Dexmedetomidine (D) group, where Dex. (Precedex, hospira, Egypt) 0.8 μg/kg was given intravenously over 10 min as a loading dose, and then infused at a rate of 0.4 μg/kg/h; and Placebo (P) group, where normal saline instead of Dex was given in volume (ml) and rate (ml/h) calculated related to the patient's body weight. The infusions were prepared by independent participant \& were started after induction of anaesthesia and continued 24 hrs postoperatively. All children were assessed thoroughly preoperatively by history taking, physical examination \& laboratory investigations (complete blood count, coagulation profile liver function \& kidney functions.) At the night before surgery, base line value of serum creatinine, creatinine clearance were obtained using standard laboratory methods. Also, base line value of serum cystatin C and NGAL were obtained using commercially available kits (Roche Diagnostics, Mannheim, Germany) \& (Biosite Incorporated, San Diego, CA, USA) respectively by ELISA method. Establishment of method and degree of sample dilution were carried out prior to analysis according to manufacture instruction.
All children were premedicated orally with midazolam 0.5 mg/ k.g 30 minutes before induction, and they were instructed to void just before admission to the operating room.
In the operating theater, all patients were monitored throughout surgery by continuous electrocardiography, heart rate, pulse oximetry, non invasive blood pressure and end tidal capnography by (Datex-Omeda model S/5) monitor. Induction was carried out with fentanyl (1-1.5 μg/kg), and propofol (1-2 mg/kg). For facilitating endotracheal intubation, atracurium was administered at an initial dose of 0.5 mg/kg followed by boluses of 0.03 mg/kg every 20-40 min. Under aseptic technique, an arterial line and central venous catheter were inserted \& Anaesthesia was maintained using isoflurane 1-2% in oxygen, and patients were mechanically ventilated. Fentanyl and atracurium increments were given as required.
The diagnostic criteria of AKI was classified according to the Acute Kidney Injury Network (AKIN) criteria as follows: the renal function decreased rapidly within 48 hours, the s Cr level increased by ≥ 26.5 µ mol/L or ≥ 1.5 times from baseline, or urine output < 0.5 mL/kg/h for > 6 hours. Oliguria is defined as urine output < 0.5 ml/kg/h. After exclusion of catheter obstruction, patients were managed with good hydration. If it persists, 10 mg I.v Lasix was given, that could be repeated twice. If no response, nephrology consultation was ordered. At the end of surgery, muscle relaxants were reversed by neostigmine 0.04-0.06 mg/kg and atropine 0.02 mg/kg, and then the patients were extubated after returning to full muscle power. All patients were monitored in the intensive care unit for 2 days after surgery, with attention to fluid balance and urine output. Serum creatinine, creatinine clearance, Cystatin C and NGAL was assessed 24 hr before surgery, after induction of anaesthesia, 12 and 24 hrs postoperatively. Urine output was assessed intraoperatively every 1 hr and postoperatively every 6 hr in the first 24 hrs. Sedation was assessed during the first 5, 15, 30, and 60 mins in the recovery room by the investigator using a five-point sedation scale. Sedation level: Agitated = 4, Awake= 3, Drowsy= 2, Asleep= 1. A sedation score of 3 \& above was considered as unsatistisfactory while 1\&2 is considered to be satisfactory. Postoperative pain was assessed using the visual analog scale from 0-10, where 0= no pain and 10= unbearable pain.
Data management Data were fed to the computer and analyzed using IBM SPSS software package version 20.0 (Armonk, NY: IBM Corp). Quantitative data were described using range (minimum and maximum), mean, SD, and median. Significance of the obtained results was judged at the 5% level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Patients were randomly allocated into 3 equal groups (25 patients each): Group (C): caudal group, where caudal anaesthesia was given using 1 mL/kg dose of 0.25% bupivacaine without epinephrine. Dexmedetomidine (D) group, where Dex. (Precedex, hospira, Egypt) 0.8 μg/kg was given intravenously over 10 min as a loading dose, and then infused at a rate of 0.4 μg/kg/h; and Placebo (P) group, where normal saline instead of Dex was given in volume (ml) and rate (ml/h) calculated related to the patient's body weight.
| Arm | Type | Receives |
|---|---|---|
| Group (C) | Active comparator | Drug: bupivacainecaudal group, where caudal anaesthesia was given using 1 mL/kg dose of 0.25% bupivacaine without epinephrine. |
| Group (D) | Active comparator | Drug: DexmedetomidineDexmedetomidine (D) group, where Dex. (Precedex, hospira, Egypt) 0.8 μg/kg was given intravenously over 10 min as a loading dose, and then infused at a rate of 0.4 μg/kg/h |
| Group (P) | Placebo comparator | Drug: normal SalinePlacebo (P) group, where normal saline instead of Dex was given in volume (ml) and rate (ml/h) calculated related to the patient's body weight. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients aged 5-10 years undergoing elective RN
Key exclusion criteria (1 listed)
- had history of use of α 2-agonists to treat hypertension, renal impairment (creatinine clearance < 90 ml/min), and persistent intraoperative hypotension [mean arterial blood pressure < 65 for > 20 min]. Also those with bleeding disorders and skin lesion at puncture site.
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 |
|---|---|---|
| DexmedetomidineAlso: preceedex0.5 mic /kg dexmedetomedine is injected after induction of anaesthesia. | Drug | Group (D) |
| bupivacaine0.25% bupivacaine is injected in the caudal epidural space | Drug | Group (C) |
| normal SalineAlso: 0.9 % Naclinjection of normal Saline | Drug | Group (P) |
Primary outcome
cystatin C
Time frame: immediately after induction
Early biomarkers in detection of renal impairment
cystatin C
Time frame: after 12 hours post-operatively
Early biomarkers in detection of renal impairment
NGAL
Time frame: immediately after induction
Early biomarkers in detection of renal impairment
NGAL
Time frame: after 12 hours post-operatively
Early biomarkers in detection of renal impairment
6 secondary outcomes
serum creatinine
Time frame: immediately after induction
serum creatinine
Time frame: after 12 hours post-operatively
creatinine clearance
Time frame: immediately after induction
creatinine clearance
Time frame: after 12 hours post-operatively
sedation score
Time frame: 5 mins post-operative
sedation score
Time frame: 60 mins post-operative
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 Mar 2022.
- 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.
Hassan S ElHoshy, lecturer study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine, bupivacaine and normal Saline in people with Renal Injury and Child, Only, run by Alexandria 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 1 inclusion and 1 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 Mar 2022. 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. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
cystatin C (time frame: immediately after induction). The study lists 4 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 Mar 2022.