HEmoFiltration With Citric Acid Anticoagulation

NCT03836742 | Completed

• 1 other identifier: NKBBN/539/2016-17
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational study of all consecutive cardio-vascular surgical patients treated with post-dilution hemofiltration with regional citrate anticoagulation as first-choice anticoagulation method. The filter life-span was assessed in the context of postoperative cardiac surgical antithrombotic prophylaxis. Reasons for termination of hemofiltration sessions were assessed. The second aim of this study was to assess the influence ACD-A based anticoagulation protocol on acid-base and ion homeostasis in cardiac surgical patients with acute renal failure.

Conditions

Acute Kidney Injury; Acute Kidney Failure; Renal Replacement Therapy; Hemofiltration

Outcome Measures

Primary Outcomes (3)

• Hemofiltration circuit survival time

  in hours

  up to 120 hours from the beginning of hemofiltration session

• Incidence of metabolic alkalosis

  Arterial blood pH\>7.5 or BE \> 40 mmol/L

  From the beginning of hemofiltration session until 6 hours after its end

• Incidence of hypernatremia and hyponatremia

  Incidence of hypernatremia\> 150 mmol/L and hyponatremia \< 130 mmol/L in arterial blood sample

  From the beginning of hemofiltration session until 6 hours after its end

Secondary Outcomes (1)

• Incidence of citrate accumulation

  From the beginning of hemofiltration session until 24 hours after its end

Study Arms (1)

HF RCA

Cardiovascular surgery patients treated with hemofiltration with regional citrate anticoagulation

Procedure: Hemofiltration with regional citrate anticoagulation

Interventions

Hemofiltration with regional citrate anticoagulation PROCEDURE

To reduce risk of metabolic alkalosis during hemofiltration treatment, ACD-A citrate solution was proposed instead of most commonly used trisodium citrate solution and relatively low target citrate concentration (2.8 mmol/L) was adopted. In case of pH increase above 7.5 or bicarbonate concentration above 40 mmol/L filtrate flow was decreased from initial 35 ml/kg/hour down to 25 ml/kg/hour which reduced bicarbonate delivery by 25%. If metabolic alkalosis persisted, the second step involved reduction of blood flow from initial 5 times down to 4 times filtrate flow, which reduced citrate flow by the same factor.

HF RCA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive cardio-vascular surgery patients treated with post-dilution hemofiltration with regional citrate anticoagulation from August 2015 through November 2017

You may qualify if:

• cardiac and vascular surgery patients treated with continuous hemofiltration with regional citrate anticoagulation

You may not qualify if:

• severe chronic liver disease, acute liver injury with INR \> 2, and refractory shock with lactate increasing above 8 mmol/L

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Romuald Lango

Gdansk, Polska, 80-516, Poland

Location

Related Publications (1)

• Kirwan CJ, Hutchison R, Ghabina S, Schwarze S, Beane A, Ramsay S, Thompson E, Prowle JR. Implementation of a Simplified Regional Citrate Anticoagulation Protocol for Post-Dilution Continuous Hemofiltration Using a Bicarbonate Buffered, Calcium Containing Replacement Solution. Blood Purif. 2016;42(4):349-355. doi: 10.1159/000452755. Epub 2016 Nov 19.

  PMID: 27866200 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Hemofiltration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Romuald Lango

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 11, 2019
• Study Start: August 11, 2015
• Primary Completion: November 10, 2017
• Study Completion: December 31, 2017
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)