Low Dialysate Temperature During SLED

NCT ID: NCT03397992

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-16
• Study Completion Date: 2017-04-22

Brief Summary

Objectives: This study is evaluating the hemodynamic effects of lowering the dialysate temperature in acute kidney injury (AKI) patients submitted to sustained low efficiency dialysis (SLED) in a single large center.

Methods: Participants will be randomly assigned to two treatment groups. One group will be started treatment with low temperature (set point 5 on the machine which is around 35°C) for one treatment and then alternate between high and low temperatures for a maximum of 8 treatments. The other group will be started with high temperature (set point 9 on the machine which is around 37°C) for the first treatment then alternate between high and low temperatures for a maximum of 8 treatments. Each participants will need at least two treatments, one with each temperature to be included in the analysis. The investigators will be looking for the number of events during a SLED treatment. Events will be defined as drop in systolic blood pressure ≥ 20 mmHg or drop in mean arterial pressure (MAP) of ≥10 mmHg, requirement of resuscitation with IVF after initiation of SLED, initiation or increase requirement of vasoactive drugs.

Conditions

Acute Kidney Injury; Intra-dialytic Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group A

Treatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter.

Group Type: ACTIVE_COMPARATOR

Changing dialysate temperature

Intervention Type: OTHER

Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)

Group B

Treatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter

Group Type: ACTIVE_COMPARATOR

Changing dialysate temperature

Intervention Type: OTHER

Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)

Interventions

Changing dialysate temperature

Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older, AKI stage 3 requiring RRT, maximum two pressers, initial temperature of 36°C or higher.

Exclusion Criteria

• Initial temperature less than 36°C, ESRD, three or more pressers, requirement of antihypertensive medications.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Fahad Edrees

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Edrees FY, Katari S, Baty JD, Vijayan A. A Pilot Study Evaluating the Effect of Cooler Dialysate Temperature on Hemodynamic Stability During Prolonged Intermittent Renal Replacement Therapy in Acute Kidney Injury. Crit Care Med. 2019 Feb;47(2):e74-e80. doi: 10.1097/CCM.0000000000003508.

Reference Type: DERIVED

PMID: 30394919 (View on PubMed)

Other Identifiers

201612031

Identifier Type: -

Identifier Source: org_study_id