NCT03665311

Brief Summary

Objective: The primary aim of this 60 patient feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

July 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

July 19, 2018

Last Update Submit

June 15, 2020

Conditions

Renal Replacement TherapyAcute Kidney InjuryHypotension

Keywords

AlbuminNormal SalineDialysisIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Recruitment rate

    Percentage of eligible patients that are successfully recruited into the study

    24 months

Secondary Outcomes (6)

  • Adherence to intervention

    Through study completion, on average 1 year.

  • Completeness of follow-up

    24 months

  • Volume removal achieved during SLED sessions

    Through study completion, on average 1 year.

  • New or increased vasopressor use during SLED sessions

    Through study completion, on average 1 year.

  • Change in mean arterial blood pressure (MAP) < 55 mmHg during SLED sessions

    Through study completion, on average 1 year.

  • +1 more secondary outcomes

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

100 mL 0.9% Normal Saline at the initiation of SLED and another 100 mL 0.9% Normal Saline after 4 hours of treatment

Other: Normal Saline

25% Albumin fluid

ACTIVE COMPARATOR

100 mL 25% Albumin fluid at the initiation of SLED and another 100 mL 25% Albumin fluid after 4 hours of treatment

Biological: 25% Albumin fluid

Interventions

25% Albumin fluidBIOLOGICAL

25% Albumin fluid (100 mL)

25% Albumin fluid
Normal SalineOTHER

0.9% Normal Saline (100 mL)

Normal Saline

Eligibility Criteria

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

You may qualify if:

  • age ≥ 18 yrs;
  • AKI treated with SLED (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines48).

You may not qualify if:

  • SLED initiated for non AKI-related indication (i.e. concurrent intoxication; treatment of hypothermia);
  • receiving chronic dialysis treatments;
  • history of allergic reaction to albumin;
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K2G 2H1, Canada

Location

Related Publications (2)

  • Clark EG, McIntyre L, Watpool I, Kong JWY, Ramsay T, Sabri E, Canney M, Hundemer GL, Brown PA, Sood MM, Hiremath S. Intravenous albumin for the prevention of hemodynamic instability during sustained low-efficiency dialysis: a randomized controlled feasibility trial (The SAFER-SLED Study). Ann Intensive Care. 2021 Dec 13;11(1):174. doi: 10.1186/s13613-021-00962-x.

    PMID: 34902089DERIVED

  • Clark EG, McIntyre L, Ramsay T, Tinmouth A, Knoll G, Brown PA, Watpool I, Porteous R, Montroy K, Harris S, Kong J, Hiremath S. Saline versus albumin fluid for extracorporeal removal with slow low-efficiency dialysis (SAFER-SLED): study protocol for a pilot trial. Pilot Feasibility Stud. 2019 May 30;5:72. doi: 10.1186/s40814-019-0460-3. eCollection 2019.

    PMID: 31161046DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryHypotension

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Edward G Clark, MD, MSc

    The Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The packaging for normal saline and 25% albumin will be identical (glass bottles) and be covered. The intravenous tubing will have an opaque sleeve to mask any colour discrepancy in the 2 products
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial with two parallel arms 1:1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

September 11, 2018

Study Start

March 25, 2019

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Locations

CA(1)