Major Cations Targeted Fluid Therapy In Renal Transplantation.

August 21, 2021 updated by: Marwa Ibrahim Mohamed Abdo,MD, Mansoura University

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 .

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansourah, Egypt
        • Marwa Ibrahim Mohamed Abdo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:-

- Participants with chronic renal failure scheduled for living-related kidney transplantation surgery

Exclusion Criteria:-

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: major cations
bood sample
Diagnostic test: major cations
blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 72 weeks
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
up to 72 weeks
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
up to 72 weeks
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
up to 72 weeks
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.
up to 72 weeks
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
up to 72 weeks
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
up to 72 weeks
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)
up to 72 weeks
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
up to 72 weeks
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).
up to 72 weeks
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,
up to 72 weeks
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

.
up to 72 weeks
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
up to 72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: marwa abdo, MD, Lecturer of Anesthesia and Surgical Intensive care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

August 3, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 21, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R.19.01.383

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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