Major Cations Targeted Fluid Therapy In Renal Transplantation.

Renal Transplant Failure Clinical Trial

Official title: Major Cations Targeted Fluid Therapy In Renal Transplantation.

Status Active, not recruiting

Clinical 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). 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 .

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Renal Transplant Failure

• NCT number: NCT03846869
• Study type: Interventional
• Source: Mansoura University
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2019
• Completion date: December 1, 2021