NCT03043131

Brief Summary

Metabolic acidosis is a frequent problem in cardiopulmonary bypass. The cause is poorly understood, but it appears to be multifactorial. It is assumed to be result of hypoperfusion with resultant lactatemia. And other theories include bicarbonate dilution to excessive proton activity and diluting fluid.The main three contributors for the development of metabolic acidosis are stress of anaesthesia, surgery and Cardio Pulmonary Bypass(CPB) prime.Even after research discussion and debate, there is no agreement upon ideal prime.The literature is extensive, comparing different types of colloids, colloids versus crystalloids, synthetic versus organic, and inclusion of numerous additions in an attempt to make a grossly unphysiological state the least disruptive to the body as possible

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

February 10, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

November 26, 2016

Last Update Submit

February 1, 2017

Conditions

Cardiopulmonary Bypass

Keywords

Cardiopulmonary bypass primePlasma Lyte - ARinger;s lactateAcidosis

Outcome Measures

Primary Outcomes (1)

  • Change in Serum Lactate

    Arterial blood gas analysis at before induction, five minutes after CPB, at the end of the termination of CPB, half an hour stay in the ICU soon after the patient is shifted from completion of surgery, before the patient is extubated

    Before induction, five minutes after CPB,five minutes after the termination of CPB, half an hour stay in the ICU soon after the patient is shifted from completion of surgery, before the patient is extubated

Secondary Outcomes (4)

  • Serum urea

    Immediate post op, 12 hours, 24 hours and 48 hours after surgery

  • Serum creatinine

    Immediate post op, 12 hours, 24 hours and 48 hours after surgery

  • Creatinine clearance

    Immediate post op, 12 hours, 24 hours and 48 hours after surgery

  • Serum electrolytes

    Immediate post op, 12 hours, 24 hours and 48 hours after surgery

Study Arms (2)

Ringer Lactate

ACTIVE COMPARATOR

patients randomized to this arm are given ringer's lactate solution for cardiopulmonary bypass prime, which is the standard practice

Drug: Ringer Lactate

Plasmalyte A

EXPERIMENTAL

patients randomized to this arm are given Plasma Lyte - A solution for cardiopulmonary bypass prime

Drug: Plasmalyte A

Interventions

Plasmalyte ADRUG

Plasma Lyte -A is administered intra operatively to maintain the hemodynamic status of patients

Also known as: Acetate containing balanced crystalloid solution
Plasmalyte A
Ringer LactateDRUG

Ringer's lactate is administered intra operatively to maintain the hemodynamic status of patients

Also known as: RL
Ringer Lactate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing heart valve surgeries under cardiopulmonary bypass
  • Patients undergoing coronary artery bypass graft surgeries for coronary artery disease under cardiopulmonary bypass

You may not qualify if:

  • Patients undergoing surgery for congenital heart diseases.
  • Patients of age less than 18 years.
  • Patients with liver dysfunction (Serum Bilirubin \>1.2mg %).
  • Patients with renal dysfunction (Serum Creatinine \>1.5mg %).
  • Patients with severe left ventricular dysfunction with ejection fraction \<30%.
  • Patients undergoing cardiac surgeries in emergency conditions.
  • Patients undergoing CABG along with heart valve replacement or repair.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Hett DA, Smith DC. A survey of priming solutions used for cardiopulmonary bypass. Perfusion. 1994 Jan;9(1):19-22. doi: 10.1177/026765919400900104.

    PMID: 8161863RESULT

  • Gu YJ, Boonstra PW. Selection of priming solutions for cardiopulmonary bypass in adults. Multimed Man Cardiothorac Surg. 2006 Jan 1;2006(109):mmcts.2005.001198. doi: 10.1510/mmcts.2005.001198.

    PMID: 24415398RESULT

  • Morgan TJ, Power G, Venkatesh B, Jones MA. Acid-base effects of a bicarbonate-balanced priming fluid during cardiopulmonary bypass: comparison with Plasma-Lyte 148. A randomised single-blinded study. Anaesth Intensive Care. 2008 Nov;36(6):822-9. doi: 10.1177/0310057X0803600611.

    PMID: 19115651RESULT

  • Lang W, Zander R. Prediction of dilutional acidosis based on the revised classical dilution concept for bicarbonate. J Appl Physiol (1985). 2005 Jan;98(1):62-71. doi: 10.1152/japplphysiol.00292.2004.

    PMID: 15591303RESULT

  • Emmett M, Narins RG. Clinical use of the anion gap. Medicine (Baltimore). 1977 Jan;56(1):38-54.

    PMID: 401925RESULT

  • De Jonghe B, Cheval C, Misset B, Timsit JF, Garrouste M, Montuclard L, Carlet J. Relationship between blood lactate and early hepatic dysfunction in acute circulatory failure. J Crit Care. 1999 Mar;14(1):7-11. doi: 10.1016/s0883-9441(99)90002-3.

    PMID: 10102718RESULT

  • Lilley A. The selection of priming fluids for cardiopulmonary bypass in the UK and Ireland. Perfusion. 2002 Sep;17(5):315-9. doi: 10.1191/0267659102pf538oa.

    PMID: 12243433RESULT

  • Liskaser FJ, Bellomo R, Hayhoe M, Story D, Poustie S, Smith B, Letis A, Bennett M. Role of pump prime in the etiology and pathogenesis of cardiopulmonary bypass-associated acidosis. Anesthesiology. 2000 Nov;93(5):1170-3. doi: 10.1097/00000542-200011000-00006.

    PMID: 11046201RESULT

  • Alston RP, Theodosiou C, Sanger K. Changing the priming solution from Ringer's to Hartmann's solution is associated with less metabolic acidosis during cardiopulmonary bypass. Perfusion. 2007 Nov;22(6):385-9. doi: 10.1177/0267659108089142.

    PMID: 18666740RESULT

  • Murray DM, Olhsson V, Fraser JI. Defining acidosis in postoperative cardiac patients using Stewart's method of strong ion difference. Pediatr Crit Care Med. 2004 May;5(3):240-5. doi: 10.1097/01.pcc.0000112367.50051.3b.

    PMID: 15115561RESULT

MeSH Terms

Conditions

Acidosis

Interventions

Plasmalyte ARinger's Lactate

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Harkant Singh, M.Ch

CONTACT

7087009554baryah@hotmail.com

Doniparthi Pradeep, MBBS

CONTACT

9501626593pradeepdhoni@ymail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Resident, Department of General Surgery

Study Record Dates

First Submitted

November 26, 2016

First Posted

February 3, 2017

Study Start

February 10, 2017

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 3, 2017

Record last verified: 2017-02