Thiamine Supplementation in High Risk Cardiac Surgery Patients

NCT03306732 | Completed Phase 4

• 1 other identifier: 10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial will evaluate the ability of thiamine to affect on postoperative vasoplegia in high risk cardiac surgery patients

Conditions

Cardiac Surgery

Keywords

Thiamine; Thiamine Supplementation; Vasoplegia Syndrome; Inotropic support; Cardiac surgery; Renal Failure

Outcome Measures

Primary Outcomes (2)

• Recruitment rate

  Recruitment of trial patients: successful recruitment is defined as 2 patients per week on average

  8 month

• Compliance with the protocol

  Successful compliance with protocol is defined as ≥ 90% of prescribed intervention being administered across all patients

  8 month

Secondary Outcomes (10)

• Vasoinotropic score

  3 days

• Peak lactate level after CPB weaning to 48 hours

  48 hours

• The value of postoperative peak serum creatinine concentration during 3 postoperative days

  3 days

• The incidence of acute kidney injury (AKI) according to "Kidney Disease: Improving Global Outcomes (KDIGO) criteria" during ICU stay

  30 days

• The daily incidence of cardiovascular and renal dysfunction according to Sequential Organ Failure Assessment (SOFA) score during 48 hours postoperatively

  48 hours

Study Arms (2)

Thiamine group

ACTIVE COMPARATOR

Drug: Thiamine hydrochloride (200mg) dissolved in 100 ml of normal saline

Placebo group

PLACEBO COMPARATOR

Drug: Normal saline (100ml)

Interventions

Thiamine hydrochloride (200mg) dissolved in 100 ml of normal saline DRUG

* After anesthesia induction * After separation from CPB * On the evening of the day of surgery (22:00) * On POD 1 twice a day at 8:00 and 22:00 * On POD 2 twice a day at 8:00 and 22:00 (if patient is still in ICU) * On POD 3 twice a day at 8:00 and 22:00 (if patient is still in ICU)

Thiamine group

Normal saline (100ml) DRUG

* After anesthesia induction * After separation from CPB * On the evening of the day of surgery (22:00) * On POD 1 twice a day at 8:00 and 22:00 * On POD 2 twice a day at 8:00 and 22:00 (if patient is still in ICU) * On POD 3 twice a day at 8:00 and 22:00 (if patient is still in ICU)

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Valve surgery + CABG that required cardiac surgery with CPB
• Aged 18 years or older
• Signed informed consent

You may not qualify if:

• Emergency surgery
• Chronic kidney disease of G4-G5 categories according to KDIGO criteria (at least one of the following present for \> 3 months: glomerular filtration rate ≤ 29 ml/min/1.73 m2, history of kidney transplantation)
• Known allergy to thiamine
• Pregnancy
• Current enrollment into another RCT (in the last 30 days)
• Previous enrollment and randomisation into the APPLY trial
• Administration of thiamine in the previous 30 day

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Meshalkin Research Institute of Pathology of Circulation

Novosibirsk, Russia

Location

Related Publications (4)

• Wiesen P, Van Overmeire L, Delanaye P, Dubois B, Preiser JC. Nutrition disorders during acute renal failure and renal replacement therapy. JPEN J Parenter Enteral Nutr. 2011 Mar;35(2):217-22. doi: 10.1177/0148607110377205.

  PMID: 21378251 BACKGROUND

• Seligmann H, Halkin H, Rauchfleisch S, Kaufmann N, Motro M, Vered Z, Ezra D. Thiamine deficiency in patients with congestive heart failure receiving long-term furosemide therapy: a pilot study. Am J Med. 1991 Aug;91(2):151-5. doi: 10.1016/0002-9343(91)90007-k.

  PMID: 1867241 BACKGROUND

• Donnino MW, Cocchi MN, Smithline H, Carney E, Chou PP, Salciccioli J. Coronary artery bypass graft surgery depletes plasma thiamine levels. Nutrition. 2010 Jan;26(1):133-6. doi: 10.1016/j.nut.2009.06.004.

  PMID: 20005469 BACKGROUND

• Andersen LW, Holmberg MJ, Doherty M, Khabbaz K, Lerner A, Berg KM, Donnino MW. Postoperative Lactate Levels and Hospital Length of Stay After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1454-60. doi: 10.1053/j.jvca.2015.06.007. Epub 2015 Jun 6.

  PMID: 26456273 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency

Interventions

thiamine hydrochloride; Saline Solution

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PHD Principal Investigator

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: October 11, 2017
• Study Start: October 19, 2017
• Primary Completion: May 18, 2018
• Study Completion: June 18, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

RU (1)