Citrate 4% Versus Heparinised Saline in Preventing Peripherally Inserted Central Catheter (PICC) Occlusions

NCT03114722 | Unknown Phase 2

• 1 other identifier: 2016/01420
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, randomized, non-blinded study. 1 group will be assigned the standard arm with use of heparinised saline (10U/ml) lock in between each catheter use. This is consistent with the standard procedure of PICC care in the investigators' centre. The second group will be assigned the intervention with use of 4% citrate lock (Dirinco Citra-Lock 4%) in between each catheter use.

Conditions

Occlusion

Outcome Measures

Primary Outcomes (1)

• Rate of catheter occlusion

  Compare the rates of catheter occlusion in patients who receive citrate 4% as a locking agent, versus those who receive heparinised saline (10U/ml).

  From post insertion to 6 months or until the catheter is removed, whichever is earlier.

Secondary Outcomes (3)

• Line troubleshooting

  From post insertion to 6 months or until the catheter is removed, whichever is earlier.

• Catheter associated bacteraemia

  From post insertion to 6 months or until the catheter is removed, whichever is earlier.

• Bleeding complications

  From post insertion to 6 months or until the catheter is removed, whichever is earlier.

Study Arms (2)

heparin 10U/ml

ACTIVE COMPARATOR

Heparinised saline (10U/ml) lock in between each catheter use (with standard twice weekly normal saline flushing if catheter not being used)

Drug: Heparinised saline (10U/ml)

citrate 4%

EXPERIMENTAL

4% citrate lock in between each catheter use (with standard twice weekly normal saline flushing if catheter not being used)

Drug: Citrate 4%

Interventions

Citrate 4% DRUG

In patients randomised to the citrate arm, the PICC line will be locked with a total of 1.6ml of citrate 4% (0.8ml per lumen in a double-lumen PICC), between each use. Lines will also be flushed with 20ml of normal saline and locked with the locking agent twice a week, if the time elapsed between each use is more than one week. This is part of the standard local protocol. Patients will be followed for up to 6 months or until the catheter is removed, or until the study ends

citrate 4%

Heparinised saline (10U/ml) DRUG

In patients randomised to the heparinised saline arm, the PICC line will be locked with 10U/ml heparinised saline between each use. Lines will also be flushed with 20ml of normal saline and locked with the locking agent twice a week, if the time elapsed between each use is more than one week. This is part of the standard local protocol. Patients will be followed for up to 6 months or until the catheter is removed, or until the study ends

heparin 10U/ml

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than or equal to 21 years.
• Histologic or cytologic diagnosis of haematological or oncological malignancy
• Signed informed consent from patient or legal representative
• Patients on antiplatelet therapy may be recruited to the study

You may not qualify if:

• Pregnancy.
• Anticoagulation - warfarin or heparin or novel oral anticoagulants
• Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

Nationa University Hospital

Singapore, Singapore

Location

Related Publications (4)

• Macrae JM, Dojcinovic I, Djurdjev O, Jung B, Shalansky S, Levin A, Kiaii M. Citrate 4% versus heparin and the reduction of thrombosis study (CHARTS). Clin J Am Soc Nephrol. 2008 Mar;3(2):369-74. doi: 10.2215/CJN.01760407.

  PMID: 18308996 BACKGROUND

• Grudzinski L, Quinan P, Kwok S, Pierratos A. Sodium citrate 4% locking solution for central venous dialysis catheters--an effective, more cost-efficient alternative to heparin. Nephrol Dial Transplant. 2007 Feb;22(2):471-6. doi: 10.1093/ndt/gfl606. Epub 2006 Oct 25.

  PMID: 17065193 BACKGROUND

• Weijmer MC, Debets-Ossenkopp YJ, Van De Vondervoort FJ, ter Wee PM. Superior antimicrobial activity of trisodium citrate over heparin for catheter locking. Nephrol Dial Transplant. 2002 Dec;17(12):2189-95. doi: 10.1093/ndt/17.12.2189.

  PMID: 12454232 BACKGROUND

• Strauss RG. Mechanisms of adverse effects during hemapheresis. J Clin Apher. 1996;11(3):160-4. doi: 10.1002/(SICI)1098-1101(1996)11:33.0.CO;2-9.

  PMID: 8915821 BACKGROUND

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Soo Chin Lee

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Chin Lee

CONTACT

(65) 6779 5555; soo_chin_lee@nuhs.edu.sg

Joan Choo Rou-En

CONTACT

(65) 6779 5555; joan_re_choo@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 14, 2017
• Study Start: July 31, 2017
• Primary Completion: July 31, 2018
• Study Completion: December 30, 2018
• Last Updated: June 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)