| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyponatremia With Excess Extracellular Fluid Volume Cirrhosis, Liver | Drug: Albumin treatment | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 52 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Albumin for Management of Hypervolemic Hyponatremia in Patients With Decompensated Cirrhosis. A Proof of Concept Study. |
| Estimated Study Start Date : | July 2020 |
| Estimated Primary Completion Date : | July 2022 |
| Estimated Study Completion Date : | November 2022 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: No treatment
No treatment.
|
|
|
Experimental: Albumin treatment
one dose per day of a 40g albumin g/l gram(s)/litre for 10 days.
|
Drug: Albumin treatment
one dose per day of a 40g albumin g/l gram(s)/litre for 10 days. resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period
Other Name: Human Albumin Grifols 200 g/l, solution for infusion
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
This study will include patients with liver cirrhosis and hypervolemic hyponatremia (serum sodium<130 mEq/L) admitted to hospital for any decompensation of the disease. Patients will be enrolled if hyponatremia persists after 3 days of diuretic withdrawal and fluid restriction. Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner. Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
Exclusion Criteria:
Active infection apart from spontaneous bacterial peritonytis based on positive culture (blood, urine, sputum or other samples) or by the following criteria:
| Contact: Anna Cruceta | 0034 93 2279838 | acruceta@clinic.ub.es |
| Spain | |
| Hospital Clinic de Barcelona | |
| Barcelona, Catalunya, Spain, 08036 | |
| Hospital Moises Broggi | |
| Barcelona, Catalunya, Spain | |
| Hospital Parc Taulí | |
| Sabadell, Catalunya, Spain, 08208 | |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | March 28, 2019 | ||||||
| First Posted Date ICMJE | May 8, 2019 | ||||||
| Last Update Posted Date | February 5, 2020 | ||||||
| Estimated Study Start Date ICMJE | July 2020 | ||||||
| Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Resolution of hyponatremia [ Time Frame: for at least 48 consecutive hours during the 10-day treatment ] defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L
|
||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Albumin for Management of Hypervolemic Hyponatremia (AlbuCAT) | ||||||
| Official Title ICMJE | Albumin for Management of Hypervolemic Hyponatremia in Patients With Decompensated Cirrhosis. A Proof of Concept Study. | ||||||
| Brief Summary | resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
| Condition ICMJE |
|
||||||
| Intervention ICMJE | Drug: Albumin treatment
one dose per day of a 40g albumin g/l gram(s)/litre for 10 days. resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period
Other Name: Human Albumin Grifols 200 g/l, solution for infusion
|
||||||
| Study Arms ICMJE |
|
||||||
| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||
| Estimated Enrollment ICMJE |
52 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | November 2022 | ||||||
| Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
This study will include patients with liver cirrhosis and hypervolemic hyponatremia (serum sodium<130 mEq/L) admitted to hospital for any decompensation of the disease. Patients will be enrolled if hyponatremia persists after 3 days of diuretic withdrawal and fluid restriction. Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner. Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function. Exclusion Criteria:
|
||||||
| Sex/Gender ICMJE |
|
||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
|
||||||
| Listed Location Countries ICMJE | Spain | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03941405 | ||||||
| Other Study ID Numbers ICMJE | 2019-000302-29 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
|
||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica | ||||||
| Study Sponsor ICMJE | Fundacion Clinic per a la Recerca Biomédica | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Fundacion Clinic per a la Recerca Biomédica | ||||||
| Verification Date | February 2020 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||