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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Haasan Elhoshy

    Alexandria, 21615

Other trials in Egypt

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.

  1. 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.

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 groups in NCT05271253
Study groupRoleWhat they receive
Group (C)Active comparatorcaudal group, where caudal anaesthesia was given using 1 mL/kg dose of 0.25% bupivacaine without epinephrine.
Receives: Drug: bupivacaine
Group (D)Active comparatorDexmedetomidine (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 comparatorPlacebo (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.

  1. cystatin C

    Early biomarkers in detection of renal impairment

    Measured: immediately after induction

  2. cystatin C

    Early biomarkers in detection of renal impairment

    Measured: after 12 hours post-operatively

  3. NGAL

    Early biomarkers in detection of renal impairment

    Measured: immediately after induction

  4. NGAL

    Early biomarkers in detection of renal impairment

    Measured: after 12 hours post-operatively

Secondary outcomes (6)
  1. serum creatinine

    conventional renal function tests

    Measured: immediately after induction

  2. serum creatinine

    conventional renal function tests

    Measured: after 12 hours post-operatively

  3. creatinine clearance

    conventional renal function tests

    Measured: immediately after induction

  4. creatinine clearance

    conventional renal function tests

    Measured: after 12 hours post-operatively

  5. 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

  6. 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.

  1. First posted9 Mar 2022
  2. Study start10 Apr 2021
  3. Primary completion29 Nov 2021
  4. Study completion15 Jan 2022

Resources

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)
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

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.

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