Major Cations Targeted Fluid Therapy In Renal Transplantation.

NCT03846869 | Unknown DMC

• 1 other identifier: R.19.01.383
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Renal Transplant Failure

Keywords

Fluid Therapy; Anesthesia; Renal Transplantation

Outcome Measures

Primary Outcomes (13)

• 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.

  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

  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

  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

  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.

  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

  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

  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)

  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

  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).

  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,

  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 .

  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

  up to 72 weeks

Study Arms (1)

major cations

EXPERIMENTAL

bood sample

Diagnostic Test: major cations

Interventions

major cations DIAGNOSTIC_TEST

blood sample

major cations

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Marwa Ibrahim Mohamed Abdo

Al Mansurah, Egypt

Location

Related Publications (16)

• 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.

  PMID: 29988941 BACKGROUND

• Aitken 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

• 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.

  PMID: 21929642 BACKGROUND

• Benjamin S Martinez, Irina Gasanova and Adebola O Adesanya (2013) . Anesthesia for Kidney Transplantation-A ReviewAne. J Anesth Clin Res 4: 2

  BACKGROUND

• 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.

  PMID: 28255797 BACKGROUND

• Chaumont 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.

  PMID: 26448870 BACKGROUND

• Othman 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.

  PMID: 20418304 BACKGROUND

• Gezer 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.

  PMID: 27437520 BACKGROUND

• Aulakh 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.

  PMID: 25948896 BACKGROUND

• Noritomi 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.

  PMID: 22086530 BACKGROUND

• Potura 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.

  PMID: 25185593 BACKGROUND

• Schmid S, Jungwirth B. Anaesthesia for renal transplant surgery: an update. Eur J Anaesthesiol. 2012 Dec;29(12):552-8. doi: 10.1097/EJA.0b013e32835925fc.

  PMID: 23010898 BACKGROUND

• Yarlagadda 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.

  PMID: 18408075 BACKGROUND

• Toth 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.

  PMID: 9850443 BACKGROUND

• Baxi V, Jain A, Dasgupta D. Anaesthesia for renal transplantation: an update. Indian J Anaesth. 2009 Apr;53(2):139-47.

  PMID: 20640114 BACKGROUND

• Yee J, Parasuraman R, Narins RG. Selective review of key perioperative renal-electrolyte disturbances in chronic renal failure patients. Chest. 1999 May;115(5 Suppl):149S-157S. doi: 10.1378/chest.115.suppl_2.149s.

  PMID: 10331349 BACKGROUND

Study Officials

• marwa abdo, MD

  Lecturer of anesthesia and surgical intensive care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical intensive care unit principal investigator

Model Details: Prospective Cohort Study

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 20, 2019
• Study Start: February 1, 2019
• Primary Completion: August 3, 2021
• Study Completion: December 1, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

EG (1)