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Comparing Combination of Diuretics And Dialysis for Treating Severe High Potassium:A Pilot Study

Comparison Of Sequential Blockade Of Nephron Using Diuretics Versus Hemodialysis For The Management Of Refractory Hyperkalemia:A Pilot Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091950
Enrollment
40
Registered
2025-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N184- Chronic kidney disease, stage 4 (severe) Health Condition 2: N181- Chronic kidney disease, stage 1 Health Condition 3: N182- Chronic kidney disease, stage 2 (mild) Health Condition 4: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 5: N170- Acute kidney failure with tubularnecrosis Health Condition 6: N171- Acute kidney failure with acute cortical necrosis Health Condition 7: N178- Other acute kidney failure Health Condition 8: N179- Acute kidney failu

Interventions

Intervention1: A Loop Diuretic+ A Thiazide + Acetazolamide: Inj.Furosemide 160 mg IV once + Inj.Chlorthiazide 1000 mg IV once OR Tab. Metolazone 10 mg once+ Acetazolamide 500 mg IV/PO once Control In

Sponsors

Department Of Emergency Medicine,AIIMS,New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Serum Potassium more than 5.5 mEq/L after initial standard medical therapy. 2)Patients with preserved urine output(more than or equal to 30 mL/hour). 3)Patients with underlying CKD or AKI not on dialysis,or on Maintenance Hemodialysis but presenting in between sessions. 4)Hemodynamically stable or managable on minimal support.

Exclusion criteria

Exclusion criteria: 1)Patient or the legally authorized representative unable or unwilling to give consent. 2)Pregnant women 3)Anuria 4)Immediate life threatening ECG changes requiring emergency dialysis(sustained VT or VF unresponsive to initial stabilization) 5)Severe volume overload or pulmonary edema not manageable with diuretics. 6)Known allergy or contraindication to any of the drugs used in the sequential nephron blockade. 7)Urinary tract obstruction. 8)Patients of age less than 18 years.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of sequential nephron blockade with emergent hemodialysis in reducing serum potassium levels in patients presenting with refractory hyperkalemia.Timepoint: From 1 to 24 hours post procedure

Secondary

MeasureTime frame
To compare the in-hospital mortality rates associated with refractory hyperkalemia in both groups. Timepoint: Till the patient is admitted in hospital.;To compare in-hospital morbidity rates(new onset or worsening cardiac arrhythmias,fluid overload or pulmonary edema,hypotension requiring intervention,electrolyte imbalance,acute worsening of renal function,need for icu admission,prolonged hospital stay) associated with refractory hyperkalemia in both groups. Timepoint: from 1 hr to 48 hrs;To evaluate the time taken to achieve potassium correction in sequential nephron blockade group. Timepoint: From 1 to 24 hrs post intervention.;To assess adverse effects(hypovolemia,hypotension,electrolyte disturbance like hyponatremia,hypocalcemia,hypomagnesemia,diuretic induced metabolic alkalosis,ototoxicity,allergic reactions to diuretics),safety(hemodynamic instability,renal function trends,requirement of rescue dialysis,life threatening events attributable to diuretics) and tolerability(completion of full sequential nephron blockade without interruption,withold or reduce diuretics due to poor response or side effects) of sequential nephron blockade compared to hemodialysis.Timepoint: From 1 to 24 hours post intervention.;To find number of patients who get crossed over from invention arm to comparative armTimepoint: within 24 hrs post intervention

Countries

India

Contacts

Public ContactDr Nayer Jamshed

AIIMS,New Delhi

jamshednayer@gmail.com9990345682

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026