Renal Transplant FailureNCT03846869
Major Cations Targeted Fluid Therapy In Renal Transplantation.
A study testing major cations in people with Renal Transplant Failure, run by Mansoura University at 1 site in Egypt.
Trial summary
English Summary And Abstract The overall anesthetic goal for the newly transplanted kidney is to maintain intravascular volume and avoid decreased perfusion by maintaining main arterial blood pressure (MAP). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Renal Transplant Failure
- What is being tested?
- major cations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Dec 2021
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with chronic renal failure scheduled for living-related kidney transplantation surgery
Who cannot join
- participants with severe left ventricular dysfunction.
- cardiomyopathy with ejection fraction 50%.
- severe anemia (blood hemoglobin Hb5g\ dL).
- bleeding tendency .
- previously received transplants.
- experienced any surgical complications (e.g., excessive bleeding or resistant graft arterial spasm.
- any surgical difficulty such as the presence of multiple renal vessels.
Trial locations and contacts
1 site in 1 country.
About this study
English Summary And Abstract
The overall anesthetic goal for the newly transplanted kidney is to maintain intravascular volume and avoid decreased perfusion by maintaining main arterial blood pressure (MAP). The participants with end-stage renal disease(ESRD) present with electrolyte and metabolic abnormalities such as hyponatremia, hyperchloremia, hyperkalemia, hypocalcemia, hypermagnesemia and metabolic acidosis. With fluid therapy for the participants with (CKD), electrolytes are potentially affected. So there is a progressive metabolic acidosis. The debate about the type of fluid to be used in renal transplant participants is on-going.
Read more
Material and methods Place of research is the Department of Anesthesia and Surgical ICU, Urology and Nephrology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.Total duration will be assumed to conduct the search over one year. A prospective cohort study and sample size 50 participants aged18 to 40 years. Written informed consent will be obtain from the participants with chronic renal failure scheduled for living-related kidney transplantation surgery .
Basal Serum major cations Na,K,Ca,Mg and Cl, Albumine and after completion of the vascular anastomosis.Fluid therapy volume 40ml/kg From the start of surgery until the renal vessels are unclamped after completion of the vascular anastomosis. and the type of fluid is determined by major cations values. Heart rate ,Systolic, diastolic, mean arterial blood pressure,will be record after induction of anesthesia, every 30 minutes till at the time of renal artery clamping in the donor, at unclamping of the vessels , after completion of the vascular anastomosis and at the end of surgery.the investigator also record renal ischemia time.Time of onset of urine production on unclamping of the renal artery .Total urine output from unclamping of the renal vessels to the end of the surgery.Kidney turgidity will evaluated .
All participants transfer to post-anaesthesia care unit then to ICU .Daily serum creatinine, creatinine clearance, a total urine output and any renal complications will be record for first 5 days postoperatively .
Read the detailed description
Material and methods Place of research the Department of Anesthesia and Surgical ICU, Urology and Nephrology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Total duration assumed to conduct the search over one year.
Preoperative management Will be that
- All transplantations in this study will be performed by the same surgical team. All undergo participants preoperative hemodialysis 24 hours before renal transplant surgery.
- Full medical and surgical history will be taken, and
- Routine laboratory investigations (eg. blood Hb, plasma proteins, coagulation studies, serum electrolytes, blood glucose, arterial blood gases, chest radiograph, and echocardiography).
- Basal Serum major cations Na,K,Ca,Mg and Cl, Albumine
Intraoperative management will be
- On the morning of surgery intra muscular injection of Morphine 0.1mg\kg and diclofenac Na 0.6mg/kg. ketamine infusion by rate 0.1 mg /kg/ h
- Monitoring before induction of anesthesia, 5-lead electro cardio gram, pulse oximetry, and noninvasive arterial blood pressure are record. Central venus catheter will be aseptically inserted into the right internal jugular vein ,
- Induction of general anesthesia is with IV midazolam 0.15 mg/kg ,fentanyl 1micogram /kg, and sodium thiopental 5% 5mg/ kg. Endotracheal intubation is facilitated by rocuronium 0.5 mg/kg Anesthesia is maintained by sevoflurane (MAC )minimal alveolar concentration (1%) with 40% O2. Minute volume is adjusted to keep end-tidal CO2approximately 35 mm Hg.
- Fluid therapy volume 40-50 ml/kg From the start of surgery until the renal vessels are unclamped after completion of the vascular anastomosis. and the type of fluid is determined by major cations values.
K > 4.0 ml Eq/dl the investigator use saline 0.9% K<3.5ml Eq/dl us the investigator ringer acetate . k> 5.0ml Eq/dl the investigator use glucose 25% 8gm+ 10 unite insulin in saline 0.9%+salbutamol 200mg.
G Na >140ml Eq/dl the investigator use ringer acetate . Na <135ml Eq/dl the investigator use saline 0.9%. and Na bicarbonate (Na H2CO3) with dose = body weight x base deficit x 0.4 x 1/2
Cl >105 ml Eg/dl the investigator use ringer acetate. Mg<2ml Eq/dl investigator use Mg sulfate 10mg/kg infusion Ca <9ml Eq/dl investigator use Ca gluconate 10% 0.25ml/kg infusion.
- From the start of surgery until the renal vessels are unclamped after completion of the vascular anastomosis. Norepinephrine will infused using infusion pump with started rate 0.01ml/ h and will be adjusted to maintain arterial blood pressure within 25% of the basal value after unclamping at the end of vascular anastomosis or mane arterial blood pressure <60 ml mercury.
- During vascular anastomosis, all recipients will receive 500 mg prednisolone as prepared by the attending nephrologist. After completing the renal vascular anastomosis, furosemide was given in20mg increments to enhance diuresis post vascular anastomosis
- Serum major cations Na,K,Ca,Mg and Cl,Albumine and arterial blood gases will be sampled.
- Heart rate ,Systolic, diastolic, mean arterial blood pressure,will be record after induction of anesthesia, every 30 minutes till at the time of renal artery clamping in the donor(onset of ischemia), at unclamping of the vessels after completion of the vascular anastomosis (end of ischemia),and at the end of surgery.
- The investigator also record renal ischemia time.
- Time of onset of urine production on unclamping of the renal artery in minute.
- Total urine output from unclamping of the renal vessels to the end of the surgery.
- Kidney turgidity will evaluated by the surgical team members, 3-point scale: score I (soft graft), score II (moderate turgid graft), and score III (highly turgid and firm graft).
Post operative management,
- All participants will be assessed for the presence of tissue edema, especially in the conjunctiva, eyelids, face,and upper airway
- All participants had a routine postoperative chest radiograph to look for signs of pulmonary edema and to exclude pneumothorax.
- Daily serum creatinine, creatinine clearance, and total urine output will be record for 5 days postoperatively.
- the investigator also will record any renal complications in the first 5 days (e.g., acute graft rejection, acute tubular necrosis, or need for hemodialysis).
Statistical Analysis
The calculated sample size of the study will be 23 at 5% participants level of significance and 80 % power, using the following formula:
N= (Z1-α/2+Z1-β) ² σ1* σ2 / δ Z1-α/2 = 1.96 Z1-β= 0.842 σ = (Standard deviation δ = Expected difference to be detected between the sample and population α = Level of acceptability of a false positive result (level of significance=0.05) β = Level of acceptability of a false negative result (0.20)
1- β= power (0.80) The sample size will be increased to 50 participants to compensate for drop outs or protocol failures with incomplete data and to increase the study power.
- Conditions
- Renal Transplant Failure
- Being tested
- major cations
- Keywords
- Fluid Therapy, Anesthesia, Renal Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
major cationsDiagnostic test
blood sample
| Study group | Role | What they receive |
|---|---|---|
| major cations | Experimental | bood sample Receives: Diagnostic Test: major cations |
What is being measured
The primary outcome is the main question the study is designed to answer.
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum major cations Na level .
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery Na ml Eq /dl.
Measured: up to 72 weeks
good graft perfusion and early renal function for participants of renal transplantation measured by Total urine output
Total urine output from de clamping of the renal vessels to the end of the surges in ml
Measured: up to 72 weeks
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum major cations K level .
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery
,K ml Eq /dl
Measured: up to 72 weeks
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum major cations Ca level. .
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery
,Ca ml Eq /dl
Measured: up to 72 weeks
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum major cations Mg levels .
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery Mg ml Eq /dl.
Measured: up to 72 weeks
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum chloride level .
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery Choride ml Eq /dl
Measured: up to 72 weeks
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum albumin level .
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery Albumin in g
Measured: up to 72 weeks
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by arterial blood gases .
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery arterial blood gases (PH,carbon dioxide partial pressure , bicarbonate ,Base status)
Measured: up to 72 weeks
good graft perfusion and early renal function for participants of renal transplantation measured by Total urine output . .
Total urine output from de clamping of the renal vessels to the end of the surgery in ml
Measured: up to 72 weeks
good graft perfusion and early renal function for participants of renal transplantation measured by Kidney turgidity .
-Kidney turgidity will evaluated by the surgical team members, 3-point scale: score I (soft graft), score II (moderate turgid graft), and score III (highly turgid and firm graft).
Measured: up to 72 weeks
good graft perfusion and early renal function for participants of renal transplantation measured by Post operative, Daily serum creatinine,
-Post operative, Daily serum creatinine,
Measured: up to 72 weeks
good graft perfusion and early renal function for participants of renal transplantation measured by Post operative, Daily creatinine clearance .
Daily creatinine clearance
.
Measured: up to 72 weeks
good graft perfusion and early renal function for participants of renal transplantation measured by total urine output
total urine output will be recorded for 5 days post operatively in ml
Measured: up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Feb 2019
- Primary completion3 Aug 2021
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant FailureStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort Study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ibrahim Mohamed Abdo,MD, Mansoura University
- Investigators
- marwa abdo, MD, Principal investigator, Lecturer of anesthesia and surgical intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846869
- Sponsor's protocol ID
- R.19.01.383
- Status last verified
- Aug 2021
- First submitted
- 7 Feb 2019
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aref A, Zayan T, Sharma A, Halawa A. Utility of central venous pressure measurement in renal transplantation: Is it evidence based? World J Transplant. 2018 Jun 28;8(3):61-67. doi: 10.5500/wjt.v8.i3.61.
PubMed 29988941Aitken E, Stevenson R, Hanif F, Raj D, Stevenson K, et al. (2016) .Renal Transplantation: An Update for Anaesthetists. Int J Anesthetic Anesthesiol 3:052.
Siedlecki A, Irish W, Brennan DC. Delayed graft function in the kidney transplant. Am J Transplant. 2011 Nov;11(11):2279-96. doi: 10.1111/j.1600-6143.2011.03754.x. Epub 2011 Sep 19.
PubMed 21929642Benjamin S Martinez, Irina Gasanova and Adebola O Adesanya (2013) . Anesthesia for Kidney Transplantation-A ReviewAne. J Anesth Clin Res 4: 2
Pfortmueller C, Funk GC, Potura E, Reiterer C, Luf F, Kabon B, Druml W, Fleischmann E, Lindner G. Acetate-buffered crystalloid infusate versus infusion of 0.9% saline and hemodynamic stability in patients undergoing renal transplantation : Prospective, randomized, controlled trial. Wien Klin Wochenschr. 2017 Sep;129(17-18):598-604. doi: 10.1007/s00508-017-1180-4. Epub 2017 Mar 2.
PubMed 28255797Chaumont M, Racape J, Broeders N, El Mountahi F, Massart A, Baudoux T, Hougardy JM, Mikhalsky D, Hamade A, Le Moine A, Abramowicz D, Vereerstraeten P. Delayed Graft Function in Kidney Transplants: Time Evolution, Role of Acute Rejection, Risk Factors, and Impact on Patient and Graft Outcome. J Transplant. 2015;2015:163757. doi: 10.1155/2015/163757. Epub 2015 Sep 10.
PubMed 26448870Othman MM, Ismael AZ, Hammouda GE. The impact of timing of maximal crystalloid hydration on early graft function during kidney transplantation. Anesth Analg. 2010 May 1;110(5):1440-6. doi: 10.1213/ANE.0b013e3181d82ca8.
PubMed 20418304Gezer M, Bulucu F, Ozturk K, Kilic S, Kaldirim U, Eyi YE. Effectiveness of the Stewart Method in the Evaluation of Blood Gas Parameters. Turk J Emerg Med. 2016 Mar 2;15(1):3-7. doi: 10.5505/1304.7361.2014.73604. eCollection 2015 Mar.
PubMed 27437520Aulakh NK, Garg K, Bose A, Aulakh BS, Chahal HS, Aulakh GS. Influence of hemodynamics and intra-operative hydration on biochemical outcome of renal transplant recipients. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):174-9. doi: 10.4103/0970-9185.155144.
PubMed 25948896Noritomi DT, Pereira AJ, Bugano DD, Rehder PS, Silva E. Impact of Plasma-Lyte pH 7.4 on acid-base status and hemodynamics in a model of controlled hemorrhagic shock. Clinics (Sao Paulo). 2011;66(11):1969-74. doi: 10.1590/s1807-59322011001100019.
PubMed 22086530Potura E, Lindner G, Biesenbach P, Funk GC, Reiterer C, Kabon B, Schwarz C, Druml W, Fleischmann E. An acetate-buffered balanced crystalloid versus 0.9% saline in patients with end-stage renal disease undergoing cadaveric renal transplantation: a prospective randomized controlled trial. Anesth Analg. 2015 Jan;120(1):123-129. doi: 10.1213/ANE.0000000000000419.
PubMed 25185593Schmid S, Jungwirth B. Anaesthesia for renal transplant surgery: an update. Eur J Anaesthesiol. 2012 Dec;29(12):552-8. doi: 10.1097/EJA.0b013e32835925fc.
PubMed 23010898Yarlagadda SG, Coca SG, Garg AX, Doshi M, Poggio E, Marcus RJ, Parikh CR. Marked variation in the definition and diagnosis of delayed graft function: a systematic review. Nephrol Dial Transplant. 2008 Sep;23(9):2995-3003. doi: 10.1093/ndt/gfn158. Epub 2008 Apr 11.
PubMed 18408075Toth M, Reti V, Gondos T. Effect of recipients' peri-operative parameters on the outcome of kidney transplantation. Clin Transplant. 1998 Dec;12(6):511-7.
PubMed 9850443Baxi V, Jain A, Dasgupta D. Anaesthesia for renal transplantation: an update. Indian J Anaesth. 2009 Apr;53(2):139-47.
PubMed 20640114
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Major Cations Targeted Fluid Therapy In Renal Transplantation.
- ClinicalTrials.gov ID
- NCT03846869
- Acronym / sponsor ID
- R.19.01.383
- Conditions
- Renal Transplant Failure
- Keywords
- Fluid Therapy, Anesthesia, Renal Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 20 Feb 2019 (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.
English Summary And Abstract
The overall anesthetic goal for the newly transplanted kidney is to maintain intravascular volume and avoid decreased perfusion by maintaining main arterial blood pressure (MAP). The participants with end-stage renal disease(ESRD) present with electrolyte and metabolic abnormalities such as hyponatremia, hyperchloremia, hyperkalemia, hypocalcemia, hypermagnesemia and metabolic acidosis. With fluid therapy for the participants with (CKD), electrolytes are potentially affected. So there is a progressive metabolic acidosis. The debate about the type of fluid to be used in renal transplant participants is on-going.
Material and methods Place of research is the Department of Anesthesia and Surgical ICU, Urology and Nephrology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.Total duration will be assumed to conduct the search over one year. A prospective cohort study and sample size 50 participants aged18 to 40 years. Written informed consent will be obtain from the participants with chronic renal failure scheduled for living-related kidney transplantation surgery .
Basal Serum major cations Na,K,Ca,Mg and Cl, Albumine and after completion of the vascular anastomosis.Fluid therapy volume 40ml/kg From the start of surgery until the renal vessels are unclamped after completion of the vascular anastomosis. and the type of fluid is determined by major cations values. Heart rate ,Systolic, diastolic, mean arterial blood pressure,will be record after induction of anesthesia, every 30 minutes till at the time of renal artery clamping in the donor, at unclamping of the vessels , after completion of the vascular anastomosis and at the end of surgery.the investigator also record renal ischemia time.Time of onset of urine production on unclamping of the renal artery .Total urine output from unclamping of the renal vessels to the end of the surgery.Kidney turgidity will evaluated .
All participants transfer to post-anaesthesia care unit then to ICU .Daily serum creatinine, creatinine clearance, a total urine output and any renal complications will be record for first 5 days postoperatively .
Detailed description
Material and methods Place of research the Department of Anesthesia and Surgical ICU, Urology and Nephrology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Total duration assumed to conduct the search over one year.
Preoperative management Will be that
- All transplantations in this study will be performed by the same surgical team. All undergo participants preoperative hemodialysis 24 hours before renal transplant surgery.
- Full medical and surgical history will be taken, and
- Routine laboratory investigations (eg. blood Hb, plasma proteins, coagulation studies, serum electrolytes, blood glucose, arterial blood gases, chest radiograph, and echocardiography).
- Basal Serum major cations Na,K,Ca,Mg and Cl, Albumine
Intraoperative management will be
- On the morning of surgery intra muscular injection of Morphine 0.1mg\kg and diclofenac Na 0.6mg/kg. ketamine infusion by rate 0.1 mg /kg/ h
- Monitoring before induction of anesthesia, 5-lead electro cardio gram, pulse oximetry, and noninvasive arterial blood pressure are record. Central venus catheter will be aseptically inserted into the right internal jugular vein ,
- Induction of general anesthesia is with IV midazolam 0.15 mg/kg ,fentanyl 1micogram /kg, and sodium thiopental 5% 5mg/ kg. Endotracheal intubation is facilitated by rocuronium 0.5 mg/kg Anesthesia is maintained by sevoflurane (MAC )minimal alveolar concentration (1%) with 40% O2. Minute volume is adjusted to keep end-tidal CO2approximately 35 mm Hg.
- Fluid therapy volume 40-50 ml/kg From the start of surgery until the renal vessels are unclamped after completion of the vascular anastomosis. and the type of fluid is determined by major cations values.
K > 4.0 ml Eq/dl the investigator use saline 0.9% K<3.5ml Eq/dl us the investigator ringer acetate . k> 5.0ml Eq/dl the investigator use glucose 25% 8gm+ 10 unite insulin in saline 0.9%+salbutamol 200mg.
G Na >140ml Eq/dl the investigator use ringer acetate . Na <135ml Eq/dl the investigator use saline 0.9%. and Na bicarbonate (Na H2CO3) with dose = body weight x base deficit x 0.4 x 1/2
Cl >105 ml Eg/dl the investigator use ringer acetate. Mg<2ml Eq/dl investigator use Mg sulfate 10mg/kg infusion Ca <9ml Eq/dl investigator use Ca gluconate 10% 0.25ml/kg infusion.
- From the start of surgery until the renal vessels are unclamped after completion of the vascular anastomosis. Norepinephrine will infused using infusion pump with started rate 0.01ml/ h and will be adjusted to maintain arterial blood pressure within 25% of the basal value after unclamping at the end of vascular anastomosis or mane arterial blood pressure <60 ml mercury.
- During vascular anastomosis, all recipients will receive 500 mg prednisolone as prepared by the attending nephrologist. After completing the renal vascular anastomosis, furosemide was given in20mg increments to enhance diuresis post vascular anastomosis
- Serum major cations Na,K,Ca,Mg and Cl,Albumine and arterial blood gases will be sampled.
- Heart rate ,Systolic, diastolic, mean arterial blood pressure,will be record after induction of anesthesia, every 30 minutes till at the time of renal artery clamping in the donor(onset of ischemia), at unclamping of the vessels after completion of the vascular anastomosis (end of ischemia),and at the end of surgery.
- The investigator also record renal ischemia time.
- Time of onset of urine production on unclamping of the renal artery in minute.
- Total urine output from unclamping of the renal vessels to the end of the surgery.
- Kidney turgidity will evaluated by the surgical team members, 3-point scale: score I (soft graft), score II (moderate turgid graft), and score III (highly turgid and firm graft).
Post operative management,
- All participants will be assessed for the presence of tissue edema, especially in the conjunctiva, eyelids, face,and upper airway
- All participants had a routine postoperative chest radiograph to look for signs of pulmonary edema and to exclude pneumothorax.
- Daily serum creatinine, creatinine clearance, and total urine output will be record for 5 days postoperatively.
- the investigator also will record any renal complications in the first 5 days (e.g., acute graft rejection, acute tubular necrosis, or need for hemodialysis).
Statistical Analysis
The calculated sample size of the study will be 23 at 5% participants level of significance and 80 % power, using the following formula:
N= (Z1-α/2+Z1-β) ² σ1* σ2 / δ Z1-α/2 = 1.96 Z1-β= 0.842 σ = (Standard deviation δ = Expected difference to be detected between the sample and population α = Level of acceptability of a false positive result (level of significance=0.05) β = Level of acceptability of a false negative result (0.20)
1- β= power (0.80) The sample size will be increased to 50 participants to compensate for drop outs or protocol failures with incomplete data and to increase the study power.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort Study
| Arm | Type | Receives |
|---|---|---|
| major cations | Experimental | Diagnostic Test: major cationsbood sample |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants with chronic renal failure scheduled for living-related kidney transplantation surgery
Key exclusion criteria (7 listed)
- participants with severe left ventricular dysfunction.
- cardiomyopathy with ejection fraction 50%.
- severe anemia (blood hemoglobin Hb5g\ dL).
- bleeding tendency .
- previously received transplants.
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 |
|---|---|---|
| major cationsblood sample | Diagnostic test | major cations |
Primary outcome
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum major cations Na level .
Time frame: up to 72 weeks
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery Na ml Eq /dl.
good graft perfusion and early renal function for participants of renal transplantation measured by Total urine output
Time frame: up to 72 weeks
Total urine output from de clamping of the renal vessels to the end of the surges in ml
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum major cations K level .
Time frame: up to 72 weeks
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery ,K ml Eq /dl
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum major cations Ca level. .
Time frame: up to 72 weeks
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery ,Ca ml Eq /dl
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum major cations Mg levels .
Time frame: up to 72 weeks
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery Mg ml Eq /dl.
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum chloride level .
Time frame: up to 72 weeks
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery Choride ml Eq /dl
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum albumin level .
Time frame: up to 72 weeks
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery Albumin in g
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by arterial blood gases .
Time frame: up to 72 weeks
Serum major cations will be sampled basal and at the time of onset of urine production on unclamping of the renal artery arterial blood gases (PH,carbon dioxide partial pressure , bicarbonate ,Base status)
good graft perfusion and early renal function for participants of renal transplantation measured by Total urine output . .
Time frame: up to 72 weeks
Total urine output from de clamping of the renal vessels to the end of the surgery in ml
good graft perfusion and early renal function for participants of renal transplantation measured by Kidney turgidity .
Time frame: up to 72 weeks
-Kidney turgidity will evaluated by the surgical team members, 3-point scale: score I (soft graft), score II (moderate turgid graft), and score III (highly turgid and firm graft).
good graft perfusion and early renal function for participants of renal transplantation measured by Post operative, Daily serum creatinine,
Time frame: up to 72 weeks
-Post operative, Daily serum creatinine,
good graft perfusion and early renal function for participants of renal transplantation measured by Post operative, Daily creatinine clearance .
Time frame: up to 72 weeks
Daily creatinine clearance .
good graft perfusion and early renal function for participants of renal transplantation measured by total urine output
Time frame: up to 72 weeks
total urine output will be recorded for 5 days post operatively in ml
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 29988941Aref A, Zayan T, Sharma A, Halawa A. Utility of central venous pressure measurement in renal transplantation: Is it evidence based? World J Transplant. 2018 Jun 28;8(3):61-67. doi: 10.5500/wjt.v8.i3.61.
- BackgroundAitken E, Stevenson R, Hanif F, Raj D, Stevenson K, et al. (2016) .Renal Transplantation: An Update for Anaesthetists. Int J Anesthetic Anesthesiol 3:052.
- Background: PubMed 21929642Siedlecki A, Irish W, Brennan DC. Delayed graft function in the kidney transplant. Am J Transplant. 2011 Nov;11(11):2279-96. doi: 10.1111/j.1600-6143.2011.03754.x. Epub 2011 Sep 19.
- BackgroundBenjamin S Martinez, Irina Gasanova and Adebola O Adesanya (2013) . Anesthesia for Kidney Transplantation-A ReviewAne. J Anesth Clin Res 4: 2
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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.
marwa abdo, MD principal investigator
Lecturer of anesthesia and surgical intensive care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing major cations in people with Renal Transplant Failure, run by Mansoura 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 7 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 24 Aug 2021. 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.
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?
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?
normalization acid-base status, intracellular and extracellular water content and plasma electrolyte compositions measured by Serum major cations Na level . (time frame: up to 72 weeks). The study lists 13 primary outcomes in all. 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 NCT03846869, which also lists 16 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 24 Aug 2021.